Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009585785

FEI Number

3009585785

Entity Name

Acne Studios AB

City/State/Country

Spanga Stockholm, SE

Establishment Address

Finspangsgatan 51, Spanga Stockholm 163 53, SE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Acne Corp (Owner Number: 10039799)

Owner / Operator Contact Address

401 Broadway, Ste 1600, New York, NY 10013, US

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
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2012-12-20

Official Correspondent

Jay Sullivan

US Agent Details

Jay Sullivan Business: ACNE CORP Email: j.sullivan@acnestudios.com Phone: (212) 3343303

Related Public Records

Same Entity

Acne Corp

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009317586	ACNE CORP	New York, NY, US

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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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 3009585785. Last updated year: 2026. Please use registration number 3009585785 when referencing this establishment in official correspondence.