Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615839

FEI Number

3003080029

Entity Name

ZHONGSHAN TORKAI OPTICAL CO., LTD.

City/State/Country

ZHONGSHAN Guangdong, CN

Establishment Address

20th FUZHONG RD, Banfu, ZHONGSHAN Guangdong 528459, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

KILLINE OPTICAL Ltd. (Owner Number: 10023984)

Owner / Operator Contact Address

Alameda Dr. Carlos D'Assumpcao, No 335-341 Centro Hot Line Andar 21A, MACAO, MO-NOTA 00000, MO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Eyeglasses Sunglasses

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2007-12-26
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2010-09-02
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2007-12-26

Official Correspondent

No official correspondent registered.

US Agent Details

Sebastian Feye Business: ACCURATE CONSULTANTS, Inc. Email: sebastian@accuratefdaconsulting.com Phone: (619) 5170673

Related Public Records

Same Entity

KILLINE OPTICAL Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010229247	NEO OPTICAL CO., LTD	Nham Bien Ward Bac Ninh, VN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06
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

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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 9615839. Last updated year: 2026. Please use registration number 9615839 when referencing this establishment in official correspondence.