Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617805

FEI Number

3007413391

Entity Name

OKIA OPTICAL CO., LTD.

City/State/Country

KOWLOON, HK

Establishment Address

UNIT D, 5/F., HK SPINNERS IND.BLDG,, PHASE 5, 760 CHEUNG SHA WAN RD., KOWLOON --, HK

Establishment Type(s)

Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

OKIA OPTICAL CO., LTD. (Owner Number: 9036745)

Owner / Operator Contact Address

UNIT D, 5/F., HK SPINNERS IND. BLDG,, PHASE 5, 760 CHEUNG SHA WAN RD., KOWLOON, HK-NOTA --, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

QUAY EYEWEAR, MARCOLIN, SAFILO USA, FOSSIL, MOREL EYEWEAR, ALLURE ACCESSORY Non-Surgical RESPIRATOR GOWN COVER SUIT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2018-08-20
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2022-04-05
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2022-04-05
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-04-05
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	1999-03-15
FME	Gown, Examination	General Hospital	Class 1	880.6265	2022-04-05
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2022-04-05
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2022-04-05
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	1999-03-15

Official Correspondent

Sam Wong

US Agent Details

Lisa Wright Lisa Wright Business: THE VISION COUNCIL Email: fda@thevisioncouncil.org Phone: (703) 5484560

Related Public Records

Same Entity

OKIA OPTICAL CO., LTD.

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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K940726	Jay-Y Enterprises Co., Inc.	NONE-GENERIC	1994-04-11
K934837	Simon Marketing, Inc.	SUNGLASSES	1993-12-08
K852902	Yours Enterprise Co., Ltd.	METALLIC SUNGLASSES	1985-08-12
K970895	Custom Optical Frames, Inc.	CUSTOM OPTICAL SUNGLASS FRAMES	1997-05-06

Similar Registrations

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2522949	PRAIRIE PRODUCTS, INC.	DOVER, PA, US
3014937479	QUANTIGE INDUSTRY SDN BHD	Shah Alam Selangor, MY
3021343301	TAIZHOU YIZHAN OPTICAL GLASSES CO., LTD	Taizhou City Zhejiang, CN
3015005459	TAIZHOU BAILIAN GLASSES MANUFACTURING CO, LTD	Taizhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617805. Last updated year: 2026. Please use registration number 9617805 when referencing this establishment in official correspondence.