Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011074933

FEI Number

3011074933

Entity Name

GOT SHADES INTERNATIONAL

City/State/Country

City of Industry, CA, US

Establishment Address

18088 Cortney Court, City of Industry, CA 91748, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Got Shades International (Owner Number: 10047120)

Owner / Operator Contact Address

18088 Cortney Court, City of Industry, CA 91748, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Locs Biohazard Xloop Arctic Blue U&Me Eyeology Arctic Blue Giselle Locs VG Biohazard Tundra Xloop Road Warrior Mega Ten LUX360

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	2021-01-25
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2024-12-23
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2016-12-14
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2016-12-14
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2016-12-14

Official Correspondent

Wayne Chen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Got Shades International

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

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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 3011074933. Last updated year: 2026. Please use registration number 3011074933 when referencing this establishment in official correspondence.