Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027645761

FEI Number

3027645761

Entity Name

SILK'N BEAUTY LTD.

City/State/Country

Rotterdam Zuid-Holland, NL

Establishment Address

Galileistraat 17, Rotterdam Zuid-Holland 3029 AL, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Silk'n Beauty Ltd. (Owner Number: 10087179)

Owner / Operator Contact Address

Galileistraat 17, 3029 AL, Rotterdam, NL-ZH 3029, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN190039

PMA Number

N/A

All Registered Proprietary Names

Over-the-counter powered light based laser for acne Light based over the counter wrinkle reduction Over-the-counter radiofrequency coagulation device for wrinkle reduction Massager, therapeutic, electric Light based over-the-counter hair removal Brush, dermabrasion, powered Stimulator, transcutaneous electrical, aesthetic purposes Silk'n 7 Silk'n Infinity Fast Light based over the counter wrinkle reduction Powered light based non-laser surgical instrument with thermal effect Silk'n Infinity Vibrator for therapeutic use genital Light based over the counter wrinkle reduction Powered light based non-laser surgical instrument with thermal effect Flash & Go Pro Light based over the counter hair removal Motion Premium BellaFlash Pro LED light therapy mask Silk'n LED Face Mask 100 Silk'n LED Neck Mask Stimulator, muscle, powered, for muscle conditioning Titan Mini FaceTite (Titan) Mini FaceTite (Titan) MultiPlatform Titan MultiPlatform Silk'n Titan Allways FaceTite MultiPlatform FaceTite Mini powered radiofrequency toothbrush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2023-07-12
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2023-07-12
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4420	2023-07-12
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2023-07-12
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2023-07-12
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2023-07-12
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2023-07-12
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2023-07-12
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2023-07-12
KXQ	Vibrator For Therapeutic Use, Genital	Obstetrics/Gynecology	Class 2	884.5960	2023-07-12
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2023-07-12
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	Class 2	878.4810	2023-07-12
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	Class 2	878.4810	2023-07-12
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2023-11-21
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2023-11-21
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2023-11-21
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2023-07-12
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2023-09-03
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4420	2023-09-03
QMJ	Powered Radiofrequency Toothbrush	Dental	Class 2	872.6866	2023-07-12

Official Correspondent

Ahava Stein

US Agent Details

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

Related Public Records

Same Entity

Silk'n Beauty Ltd.

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
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027645761. Last updated year: 2026. Please use registration number 3027645761 when referencing this establishment in official correspondence.