Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014168883

FEI Number

3014168883

Entity Name

THELIOS USA INC

City/State/Country

Rutherford, NJ, US

Establishment Address

201 RT-17N Suite 805, Rutherford, NJ 07070, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

THELIOS S.P.A. (Owner Number: 10056328)

Owner / Operator Contact Address

ZONA INDUSTRIALE VILLANOVA SNC CAP (BL), Longarone, IT-BL 32013, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Rimowa Fendi Stella McCartney Loewe Berluti Fred Kenzo Celine Dior Givenchy Bulgari Tag Heuer Givenchy Berluti Celine Fendi Loewe Stella McCartney Rimowa Kenzo Fred Dior Tag Heuer Bulgari Vuarnet

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	2017-11-29
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2017-11-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

THELIOS S.P.A.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014159107	THELIOS S.P.A.	Longarone Belluno, IT

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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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 3014168883. Last updated year: 2026. Please use registration number 3014168883 when referencing this establishment in official correspondence.