Data / Medical devices / United States / Gome Optical Lens Company Limited

Gome Optical Lens Company Limited: FDA-registered device maker in Yonkers, NY, United States, 3 510(k) clearances

Name: Gome Optical Lens Company Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Gome Optical Lens Company Limited is registered with the FDA (registration 3015392301) in Yonkers, NY, United States. It lists 19 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 28, 2017. Registered through 2027. FDA data exported November 3, 2026.

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Get makers like this one Watch Gome Optical Lens Company Limited

FDA registration number: 3015392301
Address: 598 Tuckahoe Road, Yonkers, NY, United States, 10710
Owner or operator: Gome Optical Lens Company Limited (10060498)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: May 18, 2019
Registered through: 2027
Brand names listed: DMV Eye Test, DMVEyeTest, Disposable Medical Face Mask, DryEyeAnalyzer, Surgical N95 Respirators

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Repackager or relabeler	accessdata.fda.gov
Chart, Visual Acuity	HOX	1	Manufacturer	accessdata.fda.gov
Device, Biofeedback	HCC	2	Repackager or relabeler	accessdata.fda.gov
Digital Visual Acuity Test	QTO	1	Manufacturer	accessdata.fda.gov
Frame, Spectacle	HQZ	1	Repackager or relabeler	accessdata.fda.gov
Keratoscope, Ac-Powered	HLQ	1	Specification developer	accessdata.fda.gov
Lens, Spectacle (Prescription), For Reading Discomfort	NJH	1	Repackager or relabeler	accessdata.fda.gov
Lens, Spectacle, Non-Custom (Prescription)	HQG	1	Repackager or relabeler	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Mmp-9 Test System	PFQ	1	Repackager or relabeler	accessdata.fda.gov
Pack, Heat, Moist	IMA	1	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Repackager or relabeler	accessdata.fda.gov
Pad, Heating, Powered	IRT	2	Repackager or relabeler	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Repackager or relabeler	accessdata.fda.gov
Respirator, Surgical	MSH	2	Repackager or relabeler	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Repackager or relabeler	accessdata.fda.gov
Stereoscope, Ac-Powered	HJQ	1	Manufacturer	accessdata.fda.gov
Sunglasses (Non-Prescription Including Photosensitive)	HQY	1	Repackager or relabeler	accessdata.fda.gov
Unit, Heating, Powered	IRQ	1	Repackager or relabeler	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
July 28, 2017	K170187	Photodynamic Therapy Device	GEX	Substantially Equivalent	Uvbiotek, LLC	accessdata.fda.gov
February 9, 2016	K152898	DIODE LASER THERAPY SYSTEMS	GEX	Substantially Equivalent	Beijing Sincoheren Science and Tech. Development Co., Ltd.	accessdata.fda.gov
May 1, 2007	K070494	EPI-C PLUS	GEX	Substantially Equivalent	Espansione Marketing S.P.A	accessdata.fda.gov

Compare with other makers

Updated July 28, 2017. 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.