Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006801943

FEI Number

3006801943

Entity Name

STUDIO OPTYX

City/State/Country

Champ, MO, US

Establishment Address

2418 NORTHLINE INDUSTRIAL DR, Champ, MO 63043, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Studio Optyx (Owner Number: 9066095)

Owner / Operator Contact Address

2815 OLIVE STREET, --, Saint Louis, MO 63103, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NW77th Eyewear Erkers 1879 Copper Hinge Eyewear NW77th Erkers Fine Eyewear The Neighbors Tocco Shoogars Red Eye, Inc VIP Vision Tocco NW77th Eyewear Copper Hinge Eyewear Erkers 1879 Red Eye, Inc The Neighbors Erkers Fine Eyewear NW77th Shoogars VIP Vision

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2016-03-10
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2016-03-10

Official Correspondent

JACK ERKER

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Studio Optyx

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

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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 3006801943. Last updated year: 2026. Please use registration number 3006801943 when referencing this establishment in official correspondence.