Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020823

FEI Number

1000171147

Entity Name

GEM OPTICS SARL

City/State/Country

BELLIGNAT Ain, FR

Establishment Address

1101 RUE DE L'ANGE, BELLIGNAT Ain 01100, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GEM OPTICS Sarl (Owner Number: 8020823)

Owner / Operator Contact Address

8 Rue Vaucher, OYONNAX, FR-01 01100, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GEM OPTICS GEM OPTICS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	1983-09-27
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	1983-09-27

Official Correspondent

PIERRE MERMET-MARECHAL

US Agent Details

PIERRE MERMET-MARECHAL Business: US Agent Email: pierremm1@gmail.com Phone: (305) 5195030

Related Public Records

Same Entity

GEM OPTICS Sarl

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K940726	Jay-Y Enterprises Co., Inc.	NONE-GENERIC	1994-04-11
K934837	Simon Marketing, Inc.	SUNGLASSES	1993-12-08
K852902	Yours Enterprise Co., Ltd.	METALLIC SUNGLASSES	1985-08-12
K970895	Custom Optical Frames, Inc.	CUSTOM OPTICAL SUNGLASS FRAMES	1997-05-06
K853921	Winsburn Company , Ltd.	ALL KINDS OF SUNGLASSES	1985-10-15

Similar Registrations

Registration Number	Establishment Name	Location
3007009595	RAEN OPTICS	Oceanside, CA, US
3008137594	CHLOE SAS	PARIS Ile-de-France, FR
3042870833	GOLEADER(VIETNAM) RECREATION LIMITED	Tan Phuoc 3 Commune Dong Thap, VN
3009141079	STAGE	Sandy, UT, US
3013857947	FARFETCH ITALIA S.R.L.	MILAN Milano, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020823. Last updated year: 2026. Please use registration number 8020823 when referencing this establishment in official correspondence.