Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615810

FEI Number

3003081042

Entity Name

DARWIN OPTICAL CO., LTD.

City/State/Country

TAICHUNG, TW

Establishment Address

NO.87, 32nd RD., Industrial Zone, No 12-3 34th Rd., Industrial Zone, TAICHUNG 407, TW

Establishment Type(s)

Foreign Private Label Distributor,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DARWIN OPTICAL CO., LTD. (Owner Number: 9042342)

Owner / Operator Contact Address

NO.87, 32nd RD., IND. ZONE, TAICHUNG, TW-NOTA 407, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Darwin Polycarbonate Lens Vicozy polycarbonate lens

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2012-12-09
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2010-11-08

Official Correspondent

PI-FANG LO

US Agent Details

SAU-FEN Lo Business: SAU-FEN LO Email: theresa.lo@vicozy.com Phone: (914) 4723783

Related Public Records

Same Entity

DARWIN 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
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
K853921	Winsburn Company , Ltd.	ALL KINDS OF SUNGLASSES	1985-10-15

Similar Registrations

Registration Number	Establishment Name	Location
3007009595	RAEN OPTICS	Oceanside, CA, US
3008137594	CHLOE SAS	PARIS Ile-de-France, FR
3042870833	GOLEADER(VIETNAM) RECREATION LIMITED	Tan Phuoc 3 Commune Dong Thap, VN
3009141079	STAGE	Sandy, UT, US
3013857947	FARFETCH ITALIA S.R.L.	MILAN Milano, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615810. Last updated year: 2026. Please use registration number 9615810 when referencing this establishment in official correspondence.