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Understanding the Transition From Elipse to Allurion

If you’ve been researching swallowable gastric balloons, you’ve probably come across two names: the Elipse Balloon and the Allurion Balloon. Are they different devices? Is one better than the other? The answer is simpler than you might think: the Elipse Balloon is now the Allurion Gastric Balloon System. It’s now FDA approved in the United States and 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.

At LapBandLA, Dr. David G. Davtyan has been at the forefront of non-surgical weight loss innovation for decades. Here’s everything you need to know about the Elipse-to-Allurion transition and why this rebrand represents a major milestone for patients seeking non-surgical weight loss options.

Why Elipse Became Allurion

The Elipse Balloon was developed by Allurion Technologies, Inc. The FDA summary reports approval in 78 countries since 2015 and more than 204,000 devices distributed as of December 31, 2025. Devices are not the same as patients, since a patient can receive up to two.

As part of the US FDA approval process and a broader global brand unification strategy, the company made the decision to bring everything under one name: Allurion. The device, the digital health platform, the coaching program, and the company itself now all share the same identity.

This wasn’t a cosmetic change made on a whim. Unifying the brand under “Allurion” allowed the company to:

  • Present a cohesive identity to patients and physicians worldwide
  • Align the device name with the comprehensive Allurion Program (Connected Scale, Health Tracker, App, and coaching)
  • Streamline regulatory and marketing efforts across all markets
  • Build a single, recognizable brand that stands for innovation in non-surgical weight loss

So if you’ve been searching for “Elipse balloon FDA approved” or “Elipse vs Allurion” — now you know. They’re the same device, and Allurion is the name going forward.

What’s Different Now?

The most significant change isn’t the name — it’s the FDA PMA (Premarket Approval) that was granted on February 20, 2026.

Before this date, the Elipse Balloon was available in dozens of countries but was not approved for use in the United States. Patients who wanted the procedure had to travel abroad or wait. Now, with full FDA approval, the Allurion Gastric Balloon System is available right here in Los Angeles through Dr. Davtyan’s practice.

What changed:

  • FDA PMA approval (the FDA’s most stringent device pathway)
  • Rebranding from Elipse to Allurion Gastric Balloon System
  • Enhanced digital health platform — the Allurion Program now includes the Connected Scale, Health Tracker, and mobile App for comprehensive patient support
  • Up to 10-month program with the option for up to two balloons

What stayed the same:

  • The core technology: a swallowable capsule containing a deflated balloon
  • No endoscopy required for placement or removal
  • No anesthesia needed
  • Approximately 16-week residence time in the stomach
  • Natural passage — the balloon deflates and passes on its own
  • 15-minute office placement procedure

Is It the Same Device?

Yes, fundamentally. The Allurion Gastric Balloon System uses the same core technology as the Elipse Balloon:

  • Same polyurethane balloon material — biocompatible, safe, and designed to deflate after approximately 16 weeks
  • Same capsule delivery system — the patient swallows a capsule attached to a thin catheter, an X-ray confirms it is in the stomach, and the balloon is filled with fluid
  • Same mechanism of action — the balloon occupies space in the stomach, promoting earlier satiety and reduced food intake
  • Same natural passage — no removal procedure needed

The Allurion branding also brings enhanced digital health tools that weren’t always part of the original Elipse offering in every market. The Connected Scale syncs with the Allurion App to automatically track weight trends. The Health Tracker monitors activity levels. And the integrated lifestyle coaching program provides nutrition guidance and behavioral support throughout the treatment period.

Think of it this way: the Allurion Gastric Balloon System is the Elipse Balloon — evolved, enhanced, and now backed by US FDA approval.

The FDA Approval Game-Changer

The FDA’s Premarket Approval (PMA) is the most rigorous pathway for medical device approval in the United States. Unlike the 510(k) clearance process, PMA requires extensive clinical trial data demonstrating both safety and efficacy.

The Allurion Balloon’s FDA approval was supported by the AUDACITY clinical study, which demonstrated:

 

Allurion Program Weight loss Amy Scales 0359

Why FDA PMA approval matters for patients:

  • Safety review: FDA found a reasonable assurance of safety and effectiveness for short-term limited weight loss when used as indicated
  • Physician confidence: Doctors who may have been hesitant to offer an unapproved device can now recommend it with full regulatory backing
  • Patient trust: You can be confident that the device meets the same safety and efficacy standards as other FDA-approved medical devices
  • Insurance: Ask your plan, and ask us whether we can see patients on your plan
  • Ongoing post-market surveillance: FDA approval comes with requirements for continued safety monitoring

What This Means for Patients in Los Angeles

Dr. Davtyan has worked in bariatric care throughout his career. Board Certified by both the American Board of Surgery and the American Board of Obesity Medicine, and trained at the UCLA School of Medicine, he has decades of experience helping patients achieve lasting weight loss.

With FDA approval now in hand, Dr. Davtyan offers the Allurion Gastric Balloon System in the greater Los Angeles area. Ask the office which location places the balloon.

For patients who previously considered traveling abroad for the Elipse Balloon, the wait is over. You can now access this FDA-approved device here in Los Angeles.

The Allurion Balloon is priced at $4,000 at LapBandLA, which includes the device, placement, the full Allurion Program with Connected Scale, Health Tracker, App access, and lifestyle coaching support.

Ready to take the next step? Get the FDA-approved Allurion Balloon at LapBandLA, or explore all balloon options available through Dr. Davtyan’s practice.

Schedule Your Free Allurion Balloon Consultation

Whether you knew it as the Elipse Balloon or you’re just now discovering the Allurion Gastric Balloon System, Dr. Davtyan and the LapBandLA team are ready to help you start your weight loss journey.

Call 844-41-BALLOON to schedule your free consultation today.

Smart Capsule

Frequently Asked Questions

Was the Elipse Balloon dangerous before FDA approval?

Before February 2026 the device was not FDA approved. The FDA based its approval on the AUDACITY trial, and found a reasonable assurance of safety and effectiveness for short-term limited weight loss when used as indicated. Like all balloons, it has 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. FDA approval provides an additional layer of regulatory validation for US patients.

Is the Allurion Balloon the exact same as the Elipse Balloon?

Yes, the core device is the same — a swallowable polyurethane balloon placed via a capsule and thin catheter, with no endoscopy or anesthesia required. The Allurion branding also includes the enhanced digital health platform (Connected Scale, Health Tracker, App) and structured coaching program that make up the comprehensive Allurion Program.

Why did they change the name from Elipse to Allurion?

Allurion Technologies, the company that created the Elipse Balloon, unified its brand globally. Rather than having different names in different markets, the company brought everything — the device, the program, and the digital platform — under the single Allurion name. This coincided with the US FDA approval process.

Can I still find information about the Elipse Balloon online?

Yes, you’ll still find many articles, studies, and patient testimonials that reference the “Elipse Balloon” or “Elipse Gastric Balloon.” Results from outside the US may differ from the FDA trial. For the US-labeled device, rely on the FDA summary: 6.87% average total body weight loss at 48 weeks vs 3.09% with lifestyle therapy alone, with up to two balloons.

Is the Allurion Balloon available in the US now?

Yes. The Allurion Gastric Balloon System received FDA PMA approval on February 20, 2026, and is now available at qualified practices across the United States. Dr. Davtyan offers the Allurion Balloon in the greater Los Angeles area. Ask the office which location places it.

How much does the Allurion Balloon (formerly Elipse) cost?

At LapBandLA, the Allurion Balloon is priced at $4,000. This includes the device, placement procedure, and the full Allurion Program with Connected Scale, Health Tracker, App access, and lifestyle coaching. The national average ranges from $3,000 to $4,000. Call 844-41-BALLOON for details.