What is FDA product code QFQ?

This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.

Gastroenterology & Urology › TherapeuticIngested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

Epitomee

Name: Epitomee
Brand: Epitomee

Epitomee® is indicated to aid weight management in adults with excess weight or obesity. When taken with water, Epitomee® releases compartments filled with gel particles that form a…

Registry build 21.09.26

Epitomee® is indicated to aid weight management in adults with excess weight or obesity. When taken with water, Epitomee® releases compartments filled with gel particles that form a triangular shape in the stomach. The particles absorb water, and the compartments swell. This helps one feel full sooner and eat less. The Epitomee® capsule’s action is purely mechanical and does not involve any chemical activity.

1manufacturer

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code QFQ
Manufacturer	City	Province	Registered as	Device types
Shenzhen Bonliter Optoelectronic Co., Ltd.	Shenzhen	Guangdong	Manufacturer	2

Record

Regulatory record for Epitomee
Listed by	Epitomee Medical Ltd., Israel
FDA product code	QFQ
Device type	Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
Device class	Class 2
Regulation	21 CFR 876.5982
Establishment	Manufacturer
510(k)	K240544
Record published	2025-04-22

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Epitomee
Catalogue number	Size	Per pack	Status
6.6		14	In distribution
6.6		56	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Plenity™	Gelesis SRL	6

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K240544	2024-09-13

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.