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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 BellaVisage Hybrid is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n BellaVisage Hybrid is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains. FDA UDI
Model / Reference
BellaVisage Hybrid FDA UDI
Description
The BellaVisage Hybrid is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n BellaVisage Hybrid is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains. FDA UDI

Identifiers

Catalog Number
7290019840039 FDA UDI
Primary DI / UDI-DI
17290019840036 FDA UDI
510(k) Number
K162784 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

K162784 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 be92487e-fcd3-479f-9fc4-bd8a112f4b64 37 fields · synced May 30, 2026