FDA Approved Swallowable Weight Loss Balloon
At Davtyan Medical Weight Loss and Wellness, we are with you every step of the way, from your initial consultation through follow-up care. Under the expert guidance of Dr. David G. Davtyan, a weight loss surgeon with over 30 years of experience based in Los Angeles, countless patients have achieved transformative results, reclaiming their health, beauty, and confidence.
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The Allurion Balloon in Los Angeles is now available at LapBand Los Angeles with Dr. David G. Davtyan — an FDA-approved swallowable weight loss balloon that needs no endoscopy for placement or removal. If you’ve been searching for an Allurion balloon near me or an Allurion balloon doctor near me, your search ends here. This Allurion gastric balloon requires no surgery, no endoscopy, and no anesthesia. You simply swallow a capsule with water during a 15-minute office visit, and the balloon passes after about 16 weeks. In the FDA trial: 6.87% average total body weight loss at 48 weeks vs 3.09% with lifestyle therapy alone, with up to two balloons.
Granted FDA PMA (Premarket Approval) on February 20, 2026, the Allurion Balloon is indicated to promote short-term limited weight loss in adults aged 22 to 65 with a BMI of 30 to 40 who have had at least one unsuccessful weight-loss attempt. Dr. Davtyan, board certified by the American Board of Surgery and a diplomate of the American Board of Obesity Medicine, is proud to offer this gastric balloon without surgery in LA to patients across Southern California.
Ready to lose weight without surgery? Schedule Your Free Consultation or call 844-41-BALLOON today.
What Is the Allurion Gastric Balloon?
The Allurion gastric balloon, previously known as the Elipse Balloon, is a swallowable weight loss balloon indicated to promote short-term limited weight loss in adults aged 22 to 65 with a BMI of 30 to 40 who have had at least one unsuccessful weight-loss attempt, without surgery, endoscopy, or anesthesia. It is FDA-approved for use in the United States.
How the Smart Capsule Works
The Allurion Balloon arrives as a compact capsule made from a vegetarian-grade shell, containing a deflated polyurethane balloon attached to a thin, flexible catheter. During your brief office visit, you swallow the capsule with a glass of water — just as you would a vitamin or supplement.
Once the capsule reaches your stomach, Dr. Davtyan confirms its position with a quick X-ray. The balloon is then gently inflated through the catheter with approximately 550 mL of a specialized filling solution. After inflation is confirmed, the catheter is smoothly removed. The entire process takes about 15 minutes.
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What Happens Over 16 Weeks
The inflated balloon occupies space in your stomach, helping you feel full faster and eat smaller portions. Over approximately 16 weeks, the balloon remains in place while you build healthier eating habits with the support of the full Allurion Program. At the end of the treatment period, the balloon automatically deflates through a pre-designed release valve and passes naturally through your digestive system — no removal procedure necessary.
Clinically Proven Results
In the AUDACITY clinical study summarized by the FDA, patients had 6.87% average total body weight loss at 48 weeks vs 3.09% with lifestyle therapy alone, with up to two balloons. It is a medically supervised treatment for short-term limited weight loss.
FDA Approval — What It Means for You
On February 20, 2026, the U.S. Food and Drug Administration granted Premarket Approval (PMA) to the Allurion Balloon, making it an FDA-approved swallowable gastric balloon that needs no endoscopy for placement or removal. PMA is the FDA’s most stringent type of device approval — the same level required for heart valves and pacemakers.
The AUDACITY Study
The FDA’s approval was based largely on data from the AUDACITY (Allurion® U.S. Pivotal Study for the Assessment of the Swallowable Intragastric Balloon) trial. Key findings include:
- 6.87% average total body weight loss at 48 weeks vs 3.09% with lifestyle therapy alone, with up to two balloons.
- 6.87% average total body weight loss at 48 weeks in the FDA trial
- About 58% of patients lost at least 5% of body weight, and 32.1% lost at least 10%, at 48 weeks
- The FDA summary has no data beyond 48 weeks.
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Who the FDA Approved It For
The Allurion Balloon is indicated to promote short-term limited weight loss in adults aged 22 to 65 with a BMI of 30 to 40 who have had at least one unsuccessful weight-loss attempt. Dr. Davtyan notes that this broad eligibility range means the Allurion Balloon can help many patients who fall outside the criteria for bariatric surgery but still need a medically effective weight loss solution.
The FDA summary found that the probable benefits outweigh the probable risks for short-term limited weight loss when the device is used as indicated.
How the Allurion Balloon Works — Step by Step
At LapBand Los Angeles, we’ve designed a seamless, patient-centered experience for your Allurion Balloon procedure. Here’s exactly what to expect:
Step 1: Free Consultation
Your journey begins with a comprehensive, one-on-one consultation with Dr. Davtyan. We’ll review your medical history, discuss your weight loss goals, confirm your BMI and eligibility, and answer all of your questions. This consultation is completely free.
Step 2: Swallow the Capsule
On your procedure day, you’ll swallow the Allurion Smart Capsule with a glass of water. The capsule is small and smooth, about the size of a large multivitamin. Most patients describe it as easy and comfortable to swallow.
Step 3: X-Ray Confirmation
Dr. Davtyan uses a quick X-ray to confirm the capsule has reached your stomach. This takes only a moment and ensures optimal placement before inflation.
Step 4: Inflate the Balloon
Once positioning is confirmed, the balloon is inflated through the thin catheter with approximately 550 mL of filling solution. You may feel a sensation of fullness, which is completely normal.
Step 5: Remove the Catheter
After inflation is complete, the catheter is gently removed.
Step 6: 16 Weeks of Supported Weight Loss
Over the next 16 weeks, the Allurion Balloon works with your body to reduce hunger and portion sizes while you receive full support from the Allurion Program — including digital health tools, nutrition coaching, and regular check-ins with our team.
Step 7: Balloon Deflates and Passes Naturally
At the end of the treatment period, a time-activated release valve opens, the balloon deflates, and it passes naturally through your digestive system. None in the usual course; complications may require endoscopic or surgical intervention.
The entire placement takes about 15 minutes. Plan for at least one day off, as most patients return to work within 1-2 days.
📞 Call 844-41-BALLOON to schedule your 15-minute procedure.
The Allurion Program — More Than Just a Balloon
The Allurion Balloon is the centerpiece of a weight loss program designed to help you build healthy habits. At LapBand Los Angeles, we believe long-term weight loss success requires more than a device — it requires a complete support system.
Digital Health Suite
Every Allurion patient receives:
- Allurion Connected Scale — Automatically syncs your weight data to the Allurion App, allowing both you and our clinical team to track progress in real time.
- Allurion Health Tracker — A wearable device that monitors your activity levels, sleep patterns, and other health metrics throughout your program.
- Allurion App — Your personal dashboard for tracking meals, logging activity, reviewing progress, and staying connected with your care team.
Lifestyle Coaching and Nutrition Support
Dr. Davtyan and our team provide personalized nutrition guidance and lifestyle coaching throughout the program. You’ll learn how to make sustainable food choices, manage portion sizes, and incorporate physical activity into your routine — skills that help you maintain your results long after the balloon has passed.
Up to 10 Months of Support
The Allurion Program lasts up to 10 months, extending well beyond the 16-week balloon period. The FDA summary has no data beyond 48 weeks. The FDA-labeled program can include up to two balloons over 10 months; ask what your quote covers. In the FDA trial, 8 of 264 patients (3.0%) had device-related serious adverse events, all after balloon #2, including one gastric perforation with necrosis. The FDA summary lists death among potential adverse effects; no patient died in the trial.
Allurion Balloon Results — How Much Weight Can You Lose?
Patients consistently ask us, “How much weight will I actually lose?” Here is what the FDA trial showed.
Average Weight Loss
- 6.87% total body weight loss on average at 48 weeks — for a 200-pound patient, that’s approximately 14 pounds
- About 58% lost at least 5% of body weight and 32.1% lost at least 10% at 48 weeks
- A 3.77-point difference from lifestyle therapy alone (AUDACITY study)
- The FDA summary has no data beyond 48 weeks.
What Does That Look Like in Real Life?
| Starting Weight | 5% Loss (reached by 58.0% of trial patients at 48 weeks) | 6.87% Loss (trial average at 48 weeks) | 10% Loss (reached by 32.1% of trial patients at 48 weeks) |
|---|---|---|---|
| 180 pounds | 9 lbs | 12 lbs | 18 lbs |
| 200 pounds | 10 lbs | 14 lbs | 20 lbs |
| 220 pounds | 11 lbs | 15 lbs | 22 lbs |
| 250 pounds | 12 lbs | 17 lbs | 25 lbs |
Individual results will vary based on your commitment to the Allurion Program, dietary changes, and physical activity level. Dr. Davtyan works closely with every patient to maximize results.
See real patient timelines to understand what week-by-week progress looks like.
Allurion Balloon Cost in Los Angeles
How Much Does the Allurion Balloon Cost?
At LapBand Los Angeles, the Allurion Balloon costs $4,000. This comprehensive price includes:
- The Allurion Balloon device
- Dr. Davtyan’s professional fees
- All office visits and X-rays during the procedure
- The Allurion Connected Scale, Health Tracker, and App
- Nutrition coaching and lifestyle support throughout the program
The FDA-labeled program can include up to two balloons over 10 months; ask what your quote covers.
How Does the Cost Compare?
When you compare the Allurion Balloon to other weight loss solutions, the value becomes clear:
| Weight Loss Option | Typical Cost | Timeframe |
|---|---|---|
| Allurion Balloon | $4,000 | 16 weeks |
| GLP-1 Medications (Ozempic, Wegovy) | About $149-$449/month (ongoing) | Indefinite |
| Orbera Balloon | $6,000–$9,000 | 6 months |
| Gastric Sleeve Surgery | $15,000–$25,000 | Permanent |
GLP-1 medications like Ozempic and Wegovy cost about $149 to $449 a month through manufacturer self-pay programs in 2026, depending on the product and dose; insurance varies, and many patients regain weight when they stop. The Allurion Balloon is $4,000. The FDA-labeled program can include up to two balloons over 10 months; ask what your quote covers. The FDA summary has no data beyond 48 weeks.
Financing Options
We understand that cost is a significant consideration. Financing may be available through CareCredit or other lenders, subject to credit approval; ask about current terms.
See our complete Allurion pricing guide for a detailed cost breakdown and financing information.
Allurion Balloon vs. Other Weight Loss Options
Choosing the right weight loss solution is one of the most important decisions you’ll make. Dr. Davtyan helps every patient understand the full range of options so they can make an informed choice.
Comprehensive Comparison Table
| Feature | Allurion Balloon | Orbera Balloon | Spatz3 Balloon | Gastric Sleeve | GLP-1 Medications |
|---|---|---|---|---|---|
| Procedure | Swallow capsule | Endoscopy (placement & removal) | Endoscopy (placement & removal) | Laparoscopic surgery | Self-injection |
| Anesthesia | None | Sedation required | Sedation required | General anesthesia | None |
| Procedure Time | 15 minutes | 20–30 minutes | 20–30 minutes | 60–90 minutes | N/A (ongoing) |
| Duration in Body | ~16 weeks | 6 months | Up to 12 months | Permanent | Ongoing use required |
| Removal | Passes naturally | Endoscopy required | Endoscopy required | N/A (permanent) | N/A |
| Avg. Weight Loss | Varies | Varies | Varies | Varies | Varies |
| Recovery Time | Same day | 1–3 days | 1–3 days | 2–4 weeks | None |
| Cost | ~$4,000 | $6,000–$9,000 | $8,000–$12,000 | $15,000–$25,000 | About $149-$449/month |
| FDA Approved | Yes (PMA, Feb 2026) | Yes | Yes | Yes | Yes |
Key Takeaways
- Allurion vs. Orbera: The Allurion Balloon requires no endoscopy for placement or removal, is more affordable, and involves zero sedation. Full Allurion vs. Orbera comparison.
- Allurion vs. GLP-1s: GLP-1 medications require ongoing use and ongoing costs. Average weight loss in GLP-1 label trials was greater; the trials are not directly comparable. Allurion vs. GLP-1 medications.
- Allurion vs. Surgery: For patients who don’t qualify for or don’t want bariatric surgery, the Allurion Balloon offers short-term limited weight loss without an operation. It has its own risks, including those listed below. Explore surgical weight loss options to compare.
Looking for more gastric balloon options? Visit our page on other gastric balloon options available at our practice.
Who Is a Candidate for the Allurion Balloon?
FDA-Approved Eligibility Criteria
The Allurion Balloon is indicated for adults who meet the following criteria:
- Age: 22 to 65 years old
- BMI: 30 to 40 (Class I and Class II obesity)
- Prior weight loss attempts: At least one documented unsuccessful attempt at losing weight through diet and exercise
What BMI Qualifies?
BMI (Body Mass Index) is a measure of body weight relative to height. Here’s a quick reference:
| Height | BMI 30 (lbs) | BMI 35 (lbs) | BMI 40 (lbs) |
|---|---|---|---|
| 5’2” | 164 lbs | 191 lbs | 219 lbs |
| 5’5” | 180 pounds | 210 lbs | 240 lbs |
| 5’8” | 197 lbs | 220 lbs | 263 lbs |
| 5’10” | 209 lbs | 244 lbs | 279 lbs |
| 6’0” | 221 lbs | 258 lbs | 295 lbs |
Not sure if you qualify? Check your eligibility or call us for a quick BMI assessment.
Who May Not Be a Candidate
The FDA summary lists contraindications that include patients who:
- Have had prior bariatric surgery or gastrointestinal surgery
- Are pregnant or planning to become pregnant within the treatment period
- Have a history of a structural esophageal abnormality or paraesophageal hernia
- Have active gastric ulcers, inflammatory bowel disease, or other significant GI conditions
- Are allergic to any components of the device
- Have diagnosed bulimia, binge eating, compulsive overeating, or a similar eating-related psychological disorder
The FDA summary lists other contraindications too, including prior bowel obstruction, certain GI, heart, lung and psychiatric conditions, NSAID, anticoagulant or chronic high-dose steroid use, and cancer unless in complete remission. Dr. Davtyan reviews these during the free consultation.
Think you might be a candidate? Schedule Your Free Consultation — call 844-41-BALLOON.
Safety & Side Effects
Common Side Effects (Temporary)
Like any medical device, the Allurion Balloon may cause temporary side effects, especially during the first few days after placement. The most common include:
- Nausea — Nausea and vomiting are nearly universal in the first days, and can recur. Dr. Davtyan prescribes anti-nausea medication to keep you comfortable.
- Abdominal cramping — Mild stomach cramps as your body adjusts to the balloon. Typically resolves within 48–72 hours.
- Bloating and fullness — A sensation of fullness is expected and is actually part of how the balloon helps you eat less.
- Acid reflux — Some patients experience mild reflux in the first week, manageable with over-the-counter or prescribed medications.
Most side effects resolve within the first week. The vast majority of patients report feeling comfortable and adjusted by day 4 or 5.
Rare but Serious Risks
As with any medical procedure, there are serious risks. In the FDA trial, 8 of 264 patients (3.0%) had device-related serious adverse events, all after balloon #2, including one gastric perforation with necrosis. The FDA summary lists death among potential adverse effects; no patient died in the trial. Risks include:
- Early balloon deflation. Contact the office for persistent vomiting, severe abdominal pain, or sudden bloating
- Bowel obstruction from a deflated balloon
- Gastric ulceration or perforation (perforation occurred in 1 of 264 trial patients)
Dr. Davtyan discusses all potential risks thoroughly during your consultation and provides 24/7 contact information for any concerns during your treatment.
Safety and Screening
Dr. Davtyan is board certified by the American Board of Surgery. Screening before placement is meant to reduce risk, but it cannot remove it.
Read our week-by-week side effects guide for a detailed look at what to expect during your 16-week program.
Why Choose Dr. Davtyan for Your Allurion Balloon
Credentials
Dr. David G. Davtyan is a bariatric specialist in Los Angeles:
- Board certified — American Board of Surgery (ABS) and American Board of Obesity Medicine (ABOM)
- UCLA School of Medicine trained
- Decades of bariatric experience
- Expert in both surgical and non-surgical weight loss solutions
- Offers gastric balloon therapy and minimally invasive bariatric procedures
A Patient-First Approach
At LapBand Los Angeles, we treat every patient as an individual. Dr. Davtyan personally conducts every consultation, reviews every case, and oversees every procedure. You’ll never feel like just a number — our team is dedicated to your success from your very first call through your entire weight loss journey.
Comprehensive Aftercare
Your relationship with our practice doesn’t end when the balloon is placed. We provide ongoing monitoring, nutrition counseling, and lifestyle support throughout the entire Allurion Program. Dr. Davtyan and our clinical team are available to answer questions, adjust your plan, and celebrate your milestones along the way.
Allurion Balloon at Our Los Angeles Locations
LapBand Los Angeles offers the Allurion Balloon at locations across Southern California. No matter where you are in the greater Los Angeles area, expert care is close by.
Gastric Balloon
This non-surgical procedure uses balloons to create a feeling of fullness in your stomach. As a result, you lose weight with ease because you are eating less.
Gastric Sleeve
Gastric Sleeve Surgery has become a life-changing solution for individuals seeking significant and sustainable weight loss.
Weight Loss
Different weight loss options available that we offer.
