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Shinyeyes Inc.: FDA-registered device maker in Pasadena, CA, United States, 9 510(k) clearances and 1 PMA approval

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

Shinyeyes Inc. is registered with the FDA (registration 3012719596) in Pasadena, CA, United States. It lists 5 device types. The FDA files 9 510(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: 3012719596
Address: 178 S Euclid Ave Unit 302, Pasadena, CA, United States, 91101
Owner or operator: Shinyeyes Corp. (10052566)
Roles: Complaint file establishment
First device listed: April 1, 2017
Registered through: 2026
Brand names listed: ArtMost SoftOK, ArtMost SoftOK Multifocal Soft Contact Lenses, GOV Lens, GOV Overnight Ortho-K Lens, PVS SoftOK SiHy 1 Day Contact Lens, RG5 Overnight Ortho-K Lens

Devices it lists

Device	Product code	Class	Role	Source
Lens, Contact (Orthokeratology)	MUW	2	Complaint file establishment	accessdata.fda.gov
Lens, Contact (Other Material) - Daily	HQD	2	Complaint file establishment	accessdata.fda.gov
Lens, Contact, (Disposable)	MVN	2	Complaint file establishment	accessdata.fda.gov
Lens, Contact, Orthokeratology, Overnight	NUU	3	Complaint file establishment	accessdata.fda.gov
Lenses, Soft Contact, Daily Wear	LPL	2	Complaint file establishment	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
December 17, 2024	K242413	VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens	LPL	Substantially Equivalent	Vizionfocus, Inc.	accessdata.fda.gov
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
October 12, 2018	K182247	ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)	LPL	Substantially Equivalent	Vizionfocus, Inc.	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 18, 2014	K141280	ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS	LPL	Substantially Equivalent	Seinoh Optical Co. , Ltd.	accessdata.fda.gov
August 16, 2005	K051095	55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR	LPL	Substantially Equivalent	Optical Connection, Inc.	accessdata.fda.gov
March 19, 2004	K033594	OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES	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.