GOME OPTICAL LENS COMPANY LIMITED

FDA Device Registration & Listing · Yonkers, NY, US · Registration 3015392301

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015392301
FEI Number
3015392301
Entity Name
GOME OPTICAL LENS COMPANY LIMITED
City/State/Country
Yonkers, NY, US
Establishment Address
598 Tuckahoe Road, Yonkers, NY 10710, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Gome Optical Lens Company Limited (Owner Number: 10060498)
Owner / Operator Contact Address
598 Tuckahoe Road, Yonkers, NY 10710, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Disposable Medical Face Mask Surgical N95 Respirators DMV Eye Test DMVEyeTest

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HQZ Frame, Spectacle Ophthalmic Class 1 886.5842 2019-05-18
HCC Device, Biofeedback Neurology Class 2 882.5050 2023-10-14
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2020-03-26
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-06-26
OUG Medical Device Data System General Hospital Class 1 880.6310 2020-05-29
IRQ Unit, Heating, Powered Physical Medicine Class 1 890.5950 2023-10-14
NJH Lens, Spectacle (Prescription), For Reading Discomfort Ophthalmic Class 1 886.5844 2019-05-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-11-01
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2023-11-22
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2020-03-26
QTO Digital Visual Acuity Test Ophthalmic Class 1 886.1150 2022-10-11
IMA Pack, Heat, Moist Physical Medicine Class 1 890.5730 2023-12-10
PFQ Mmp-9 Test System Clinical Chemistry Class 1 862.1540 2025-12-08
HOX Chart, Visual Acuity Ophthalmic Class 1 886.1150 2020-05-29
HQY Sunglasses (Non-Prescription Including Photosensitive) Ophthalmic Class 1 886.5850 2019-05-18
HQG Lens, Spectacle, Non-Custom (Prescription) Ophthalmic Class 1 886.5844 2019-05-18

Official Correspondent

Eric Rubinfeld

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gome Optical Lens Company Limited
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
K873418 Bodylog, Inc. BODYLOG STRESS REDUCTION PACKAGE 1987-12-17
K792659 Bio-Feedback Systems, Inc. FEEDBACK EDR SYSTEM MODEL ME-1 1980-01-09
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0505-2022 Philips North America Llc 1
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022 Philips North America Llc 1
Infant Heel Warmers w/strap, Reference # 989805603201 1223

Similar Registrations

Registration Number Establishment Name Location
3007521479 NY2LA INC. Camarillo, CA, US
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 3015392301. Last updated year: 2026. Please use registration number 3015392301 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.