
Eligibility Criteria for the FDA-Approved Allurion Balloon
Wondering if you qualify for the Allurion Balloon? You’re not alone — one of the most common questions we hear at LapBandLA is “Am I a candidate?” The Allurion Balloon has specific BMI requirements and eligibility criteria set by the FDA, and understanding them is the first step toward determining whether this groundbreaking weight loss tool is right for you.
In this complete candidacy guide, Dr. David G. Davtyan — board certified by the American Board of Surgery and a diplomate of the American Board of Obesity Medicine — explains exactly who qualifies, who doesn’t, and what to do if you fall outside the standard criteria.
Want to find out right away? Call 844-41-BALLOON to schedule a free eligibility assessment at any of our Los Angeles-area locations.
Allurion Balloon FDA-Approved Criteria
The Allurion Balloon received FDA PMA (Premarket Approval) in February 2026. It 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. It needs no endoscopy for placement or removal in the usual course. The FDA approval established the following eligibility criteria based on the AUDACITY clinical study:
- BMI between 30 and 40 (classified as obese to severely obese)
- Age 22 to 65 years old
- At least one prior failed weight management attempt (diet, exercise, medication, or other methods)
- Not currently pregnant or planning to become pregnant during the treatment period
- No prior gastric or bariatric surgery
- No active gastrointestinal conditions that could interfere with balloon placement or safety
Dr. Davtyan evaluates every patient individually during a consultation. Meeting these basic criteria is the starting point, but your overall health picture matters too.
BMI Calculator: Check Your BMI
Your Body Mass Index (BMI) is a screening tool that estimates body fat based on your height and weight. Here’s how to calculate it:
BMI Formula
BMI = (Weight in pounds × 703) ÷ (Height in inches × Height in inches)
Example Calculations
Example 1: A person who weighs 210 pounds and is 5’6” (66 inches) tall: – 210 × 703 = 147,630 – 66 × 66 = 4,356 – 147,630 ÷ 4,356 = 33.9 BMI ✅ Qualifies
Example 2: A person who weighs 180 pounds and is 5’8” (68 inches) tall: – 180 × 703 = 126,540 – 68 × 68 = 4,624 – 126,540 ÷ 4,624 = 27.4 BMI ❌ Below minimum
Example 3: A person who weighs 250 pounds and is 5’4” (64 inches) tall: – 250 × 703 = 175,750 – 64 × 64 = 4,096 – 175,750 ÷ 4,096 = 42.9 BMI ⚠️ Above standard range (see below)
Don’t worry about doing the math yourself. Dr. Davtyan’s team will calculate your BMI accurately during your consultation and determine your eligibility.
What the BMI Ranges Mean
BMI is categorized into standard ranges recognized by the National Institutes of Health:
| BMI Range | Classification |
|---|---|
| Below 18.5 | Underweight |
| 18.5 – 24.9 | Normal weight |
| 25.0 – 29.9 | Overweight |
| 30.0 – 34.9 | Obese (Class I) |
| 35.0 – 39.9 | Severely obese (Class II) |
| 40.0 and above | Morbidly obese (Class III) |
The Allurion Balloon targets patients in the BMI 30-40 range — specifically Class I and Class II obesity. This is the population that was studied in the AUDACITY clinical trial, which demonstrated meaningful total body weight loss and more weight loss compared to diet and exercise alone.
For many patients in this BMI range, the Allurion Balloon fills a critical gap. They may not qualify for — or want — bariatric surgery, and diet alone hasn’t worked. The Allurion Balloon provides a clinically proven, non-surgical solution.
Age Requirements
The FDA approval for the Allurion Balloon specifies an age range of 22 to 65 years old. These limits exist for important reasons:
- Minimum age of 22: The AUDACITY clinical study enrolled adult participants 22 and older. The FDA data do not extend to patients under 22.
- Maximum age of 65: The FDA indication stops at age 65.
If you are close to these age boundaries, Dr. Davtyan can discuss your specific situation during a consultation. Age is one factor among many in determining the best weight loss approach for you.
Who Should NOT Get the Allurion Balloon
Certain medical conditions and circumstances make the Allurion Balloon unsuitable. Contraindications include:
- Prior gastric or bariatric surgery (gastric bypass, gastric sleeve, lap band, or any stomach surgery)
- Active gastrointestinal bleeding or ulcers
- History of a structural esophageal abnormality or paraesophageal hernia
- Inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
- Pregnancy or breastfeeding
- Blood clotting disorders or current use of anticoagulant medications
- Known or suspected allergy to polyurethane
- Esophageal conditions that could prevent safe swallowing of the capsule
- Hepatic insufficiency . The FDA summary also lists: prior bowel obstruction or small bowel surgery, intraperitoneal adhesions, perforated viscus, severe gastroparesis, varices or telangiectasias, GI tumors, inability to stop NSAIDs, chronic high-dose steroids, pancreatitis, serious heart or lung disease including severe sleep apnea, alcoholism or drug addiction, serious psychiatric illness, diagnosed binge eating or similar disorders, cancer unless in complete remission, inability to take prescribed PPI or anti-nausea medication, and placement within 2 months of another balloon
If you have any of these conditions, Dr. Davtyan will discuss alternative weight loss options that are safe and appropriate for your situation. LapBandLA offers a full range of surgical and non-surgical solutions.
What If My BMI Is Over 40?
If your BMI exceeds 40, you fall outside the standard FDA-approved range for the Allurion Balloon. However, this doesn’t necessarily mean you have no options.
A BMI over 40 is outside the FDA-labeled use. Ask Dr. Davtyan which options fit your situation.
For patients with a BMI over 40, Dr. Davtyan may also recommend:
- Gastric sleeve surgery — a highly effective surgical option for higher BMI patients
- Gastric bypass — generally for patients with a BMI of 35 or higher, or 30 to 34.9 with metabolic disease
- Other non-surgical options, reviewed at your consultation
The key is having a personalized plan. Schedule a consultation with Dr. Davtyan to explore all your options.
What If My BMI Is Under 30?
If your BMI is below 30, the Allurion Balloon is not FDA-approved for you. The clinical evidence supporting the balloon’s safety and effectiveness was established in patients with a BMI of 30 or higher.
But that doesn’t mean you’re out of options. For patients with a BMI of 25-29.9 (overweight range), Dr. Davtyan may recommend:
- Medical weight loss programs — physician-supervised plans with appetite suppressants and lifestyle coaching
- Nutritional counseling — personalized meal planning with registered dietitians
- CoolSculpting or body contouring — for stubborn fat pockets rather than overall weight loss
- GLP-1 medications — certain GLP-1 drugs are approved for patients with lower BMIs who have weight-related health conditions
Dr. Davtyan will help you find the right fit. Even if the Allurion Balloon isn’t the answer, there’s always a path forward.
Schedule a Free Eligibility Assessment
The best way to find out if you qualify for the Allurion Balloon is to come in for a free, no-obligation consultation with Dr. Davtyan. During your visit, our team will:
- Calculate your BMI accurately
- Review your complete medical history
- Discuss your prior weight loss attempts
- Evaluate any potential contraindications
- Explain the full Allurion overview — how it works, what to expect, and results
- Review the Allurion cost guide and payment options
- Discuss alternative options if the Allurion Balloon isn’t the right fit
Call 844-41-BALLOON today to schedule your free eligibility assessment. We have offices in Beverly Hills, Glendale, Rancho Cucamonga, Fountain Valley, and Marina Del Rey — with flexible scheduling to fit your life.
Frequently Asked Questions
What BMI do I need for the Allurion Balloon?
You need a BMI between 30 and 40 to qualify for the FDA-approved Allurion Balloon. This corresponds to Class I and Class II obesity. Dr. Davtyan’s team will calculate your exact BMI during your free consultation and help determine your eligibility.
Can I get the Allurion Balloon if my BMI is 29?
The Allurion Balloon is FDA-approved for BMI 30-40, so a BMI of 29 falls below the approved range. Dr. Davtyan can discuss your options at a consultation. There are other effective non-surgical weight loss solutions that may be appropriate.
What if I’ve had gastric sleeve or lap band surgery before?
Prior gastric or bariatric surgery is a contraindication for the Allurion Balloon. The altered stomach anatomy from previous surgery may not safely accommodate the balloon. Dr. Davtyan can discuss revision surgery or other alternatives during a consultation.
Is there a weight limit for the Allurion Balloon?
The FDA approval specifies a BMI range of 30-40 rather than a specific weight limit. Your BMI depends on both your weight and height. For example, a 5’6” person with a BMI of 40 weighs approximately 248 pounds, while a 6’0” person with a BMI of 40 weighs approximately 295 pounds.
Do I need to have tried other diets before qualifying?
Yes. The FDA criteria require at least one prior failed weight management attempt. This can include dieting, exercise programs, commercial weight loss programs, medication, or any other supervised attempt at weight loss. Most patients who seek out the Allurion Balloon have already tried multiple approaches.
How do I check if I’m eligible without coming in?
While online BMI calculators can give you a rough estimate, the most accurate eligibility assessment happens in person. Dr. Davtyan considers your full health history, not just your BMI. Call 844-41-BALLOON to schedule a free consultation — there’s no obligation, and you’ll leave with a clear understanding of your options.
Can I use the Allurion Balloon with a walking guide by BMI to improve my results?
Absolutely. Combining the Allurion Balloon with regular physical activity — including a structured walking program tailored to your BMI — can enhance your weight loss results and help you build habits that last long after the balloon passes.





