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510(k) Data Aggregation
K Number
K230013Device Name
Silk'n Titan Allways
Manufacturer
Silk'n Beauty Ltd.
Date Cleared
2023-08-30
(239 days)
Product Code
PAY, OHS
Regulation Number
878.4420Why did this record match?
Applicant Name (Manufacturer) :
Silk'n Beauty Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Silk'n Titan AllWays is an over-the-counter home use device intended for the non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick skin types I-IV.
Device Description
The Silk'n Titan AllWays is a cordless, hand-held device, utilizing RF energy and low power light spectrum. The device includes an RF generator, an array of 8 LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths respectively), and a temperature stabilizer. The Silk'n Titan AllWays consists of an applicator and an adaptor. The hand-held applicator delivers energy from the treatment surface at the applicator tip which comes in direct contact with the skin. The applicator is equipped with an ON/OFF switch (that also selects the energy level) and an indicators panel. The device can be powered by an internal rechargeable battery (cordless mode) or with the AC adaptor that connects the applicator to an electrical outlet.
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