Data / Medical devices / United Kingdom / Contamac Ltd.

Contamac Ltd.: FDA-registered device maker in Essex Uk, United Kingdom, 7 510(k) clearances and 1 PMA approval

Name: Contamac Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Contamac Ltd. is registered with the FDA (registration 3001190611) in Essex Uk, United Kingdom. It lists 3 device types. The FDA files 7 510(k) clearances and 1 PMA approval under its listings, the newest dated February 10, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3001190611
Address: Carlton House Shirehill, Essex Uk, United Kingdom, CB11 3AU
Owner or operator: CONTAMAC LTD. (9011725)
Roles: Manufacturer, Specification developer
First device listed: December 3, 2007
Registered through: 2026
Brand names listed: EyeFitPRO, EyePrintPRO, Hybird FS, Optimum - Hybrid, Optimum Dry EYE Lens, Optimum GP, Optimum GP OK, Optimum Infinite and more

Devices it lists

Device	Product code	Class	Role	Source
Lens, Contact (Orthokeratology)	MUW	2	Manufacturer	accessdata.fda.gov
Lens, Contact (Other Material) - Daily	HQD	2	Manufacturer	accessdata.fda.gov
Lens, Contact, Orthokeratology, Overnight	NUU	3	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 17, 2022	K212631	Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses	HQD	Substantially Equivalent	Contamac, Ltd.	accessdata.fda.gov
November 23, 2018	K182304	Hyper GP (tisilfocon A) Daily Wear Contact Lens	HQD	Substantially Equivalent	Contamac, Ltd.	accessdata.fda.gov
April 25, 2018	K180616	OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens	HQD	Substantially Equivalent	Contamac, Ltd.	accessdata.fda.gov
August 10, 2016	K161100	Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses	HQD	Substantially Equivalent	Contamac, Ltd.	accessdata.fda.gov
July 13, 2016	K160859	OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)	MUW	Substantially Equivalent	Contamac, Ltd.	accessdata.fda.gov
March 19, 2004	K033594	OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES	HQD	Substantially Equivalent	Contamac, Ltd.	accessdata.fda.gov
September 12, 2002	K021977	HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR	HQD	Substantially Equivalent	Contamac, Ltd.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
February 10, 2026	P240045	Optimum Infinite (tisilfocon A) Orthokeratology Lenses II	NUU	0	February 10, 2026	accessdata.fda.gov

Compare with other makers

Updated February 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.