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Silk'n

FDA UDI

Class II (US FDA UDI)

by Silk'N Beauty , Ltd.

Identity

Trade Name
Silk'n FDA UDI
Generic Name
Radio-frequency skin surface treatment system applicator FDA UDI
Device Name
The device is a face treatment device which utilizes Home Technology™. The device combines several kinds of energy: Low Level Laser Therapy (LLLT), Infrared and Bi-Polar Radio Frequency energy (Bi-Polar RF) that treat the upper layer, dermis and deep sub-dermal fat to improve the skin's appearance and reduce wrinkles. The device includes a treatment surface with 3 electrodes and a control button with 5 surrounding indicator lights. The device is provided with an RF Attachment which provides larger treatment surface. It has a rechargeable battery for cordless use, as well as a wall adapter for connection to the mains supply. FDA UDI
Model / Reference
Titan MultiPlatform FDA UDI
Description
The device is a face treatment device which utilizes Home Technology™. The device combines several kinds of energy: Low Level Laser Therapy (LLLT), Infrared and Bi-Polar Radio Frequency energy (Bi-Polar RF) that treat the upper layer, dermis and deep sub-dermal fat to improve the skin's appearance and reduce wrinkles. The device includes a treatment surface with 3 electrodes and a control button with 5 surrounding indicator lights. The device is provided with an RF Attachment which provides larger treatment surface. It has a rechargeable battery for cordless use, as well as a wall adapter for connection to the mains supply. FDA UDI

Identifiers

Catalog Number
7290019840237 FDA UDI
Primary DI / UDI-DI
17290019840234 FDA UDI
510(k) Number
K230013 FDA UDI
FDA Product Code
PAY FDA UDI
OHS FDA UDI
GMDN Term
Radio-frequency skin surface treatment system applicator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4420 FDA UDI
878.4810 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radio-frequency skin surface treatment system applicator

Silk'n by Silk'N Beauty , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radio-frequency skin surface treatment system applicator.

Cleared under the same submission

K230013 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Silk'N Beauty , Ltd.

Sources (1)

  • FDA UDI f4daafdb-1a3f-4637-8e66-51c7a77c77d0 37 fields · synced May 30, 2026