Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010149266

FEI Number

3010149266

Entity Name

OPTA FILAO CAROLINE ABRAM LUNETTES

City/State/Country

Romainville Ile-de-France, FR

Establishment Address

241 rue de romainville, Romainville Ile-de-France 93230, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Opta Filao Caroline Abram Lunettes (Owner Number: 10042180)

Owner / Operator Contact Address

241 rue de romainville, Romainville, FR-IDF 93230, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OPTA FILAO OPTA FILAO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2012-10-29
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2013-09-05

Official Correspondent

Katarina Miladinovic

US Agent Details

Samia Beddar Business: ADALCA STUDIO LLC Email: info@adalcastudio.com Phone: (954) 3288599

Related Public Records

Same Entity

Opta Filao Caroline Abram Lunettes

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
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06
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

Similar Registrations

Registration Number	Establishment Name	Location
3007521479	NY2LA INC.	Camarillo, CA, US
3005147601	VISIONTECH EXPORT INTERNATIONAL (PVT) LTD.	KARACHI Sindh, PK
3009554831	ROGER EYE DESIGN	Etten-Leur Noord-Brabant, NL
3013507321	DEM FACTORY S.R.L.	Limana Belluno, IT
3015243992	L.G.R SRL	Roma, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010149266. Last updated year: 2026. Please use registration number 3010149266 when referencing this establishment in official correspondence.