Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033793026

FEI Number

3033793026

Entity Name

SILKN CANADA CORP.

City/State/Country

WOODBRIDGE Ontario, CA

Establishment Address

4550 HIGHWAY 7 UNIT 206, WOODBRIDGE Ontario L4L4Y7, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

SILKN CANADA CORP. (Owner Number: 10093700)

Owner / Operator Contact Address

4550 HIGHWAY 7 UNIT 206, WOODBRIDGE, CA-ON L4L4Y7, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223544

PMA Number

N/A

All Registered Proprietary Names

Light based over the counter hair removal Motion Premium Flash & Go Pro Silk'n LED Neck Mask Silk'n Led Face Mask 100 LED light therapy mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2025-06-25
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2025-06-25
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2025-06-25
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2025-06-25
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-06-25

Official Correspondent

SANDRA COCKBURN

US Agent Details

Naphtali Deutsch Business: A. Stein Regulatory Affairs Consulting Email: ahava@asteinrac.com Phone: (888) 4433867

Related Public Records

Same Entity

SILKN CANADA CORP.

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
K192521	Shangdong Huamei Technology Co., Ltd.	Intense Pulsed Light Treatment System	2019-12-06

Similar Registrations

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3007085226	Vydence Medical Industria e Comercio Ltda	CEAT - Sao Carlos/SP Sao Paulo, BR
3043047259	BLINK BRIGHT MEDICAL, INC.	Houston, TX, US
3012799115	BEIJING GLOBALIPL DEVELOPMENT CO., LTD.	Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033793026. Last updated year: 2026. Please use registration number 3033793026 when referencing this establishment in official correspondence.