Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005516815

FEI Number

3005516815

Entity Name

MYKITA NORTH AMERICA

City/State/Country

West Orange, NJ, US

Establishment Address

80 Main St Ste 200, West Orange, NJ 07052, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

MYKITA North America (Owner Number: 10044968)

Owner / Operator Contact Address

80 Main Street, Ste 200, West Orange, NJ 07052, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MYKITA Lite MYKITA MYKITA Col No.1 MYKITA MYLON MYKITA Col No.2 MYKITA Lite MYKITA MYLON MYKITA Col No.1 MYKITA Col No.2 MYKITA

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	2013-09-03
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	2013-09-03

Official Correspondent

Marian Larkin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MYKITA North America

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 3005516815. Last updated year: 2026. Please use registration number 3005516815 when referencing this establishment in official correspondence.