Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1720959

FEI Number

1720959

Entity Name

ACCULENS, INC.

City/State/Country

Lakewood, CO, US

Establishment Address

5353 W. Colfax Ave., Lakewood, CO 80214, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Accu-Lens, Inc. (Owner Number: 10057998)

Owner / Operator Contact Address

5353 W. Colfax Ave., Lakewood, CO 80214, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Optimum Gp Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses Optimum Gp Ok

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2018-06-23
MUW	Lens, Contact (Orthokeratology)	Ophthalmic	Class 2	886.5916	2023-01-25
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2023-01-25
MUW	Lens, Contact (Orthokeratology)	Ophthalmic	Class 2	886.5916	2018-06-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Accu-Lens, Inc.

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
K963512	Benz Research and Development Corp.	BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL	1997-07-31

Similar Registrations

Registration Number	Establishment Name	Location
3032010300	TIANJIN MASTERVISION TECHNOLOGY CO., LTD.	Wuqing District Tianjin, CN
3005994941	SOLOTICA INDUSTRIA E COMERCIO LTDA	Sao Paulo, BR
3010607087	Menicon Nect Co., Ltd., Gujo Plant	Gujo Gifu, JP
1835957	ART OPTICAL CONTACT LENS, INC.	Walker, MI, US
3025308027	BIOLENS LAB	Mohammedia Mohammadia, MA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1720959. Last updated year: 2026. Please use registration number 1720959 when referencing this establishment in official correspondence.