Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043097

FEI Number

3002855268

Entity Name

IRENE Corporation

City/State/Country

TAINAN, TW

Establishment Address

No. 283, Hsin-Nan Street, South District,, TAINAN 702018, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

IRENE Corporation (Owner Number: 8043097)

Owner / Operator Contact Address

No. 283, Hsin-Nan Street, South District,, --, TAINAN, TW-TNN 702018, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NJH	Lens, Spectacle (Prescription), For Reading Discomfort	Ophthalmic	Class 1	886.5844	2020-12-08
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2013-12-17
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2000-07-19
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2020-12-08

Official Correspondent

ALICE KUO

US Agent Details

Gary Nesty Business: Solar Bat Enterprises, Inc. Email: garynesty@solarbat.com Phone: (812) 9863551

Related Public Records

Same Entity

IRENE Corporation

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

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8043274	JIANN LIH OPTICAL CO., LTD.	TAINAN City, TW
3038269608	Essilor Laboratories of America, Inc. dba Omega Northcreek Lab	Dallas, TX, US
3012981754	WEIFANG GOERTEK ELECTRONICS CO., LTD.	WEIFANG Shandong, CN
3042228518	AKRITI OPHTHALMIC PRIVATE LIMITED	Hyderabad Telangana, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043097. Last updated year: 2026. Please use registration number 8043097 when referencing this establishment in official correspondence.