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Silk'n Titan AllWays

by Home Skinovations, Ltd.

Silk'n Titan AllWays (7290112451552) is a radio-frequency skin surface treatment system (FDA Class II) made by Home Skinovations, Ltd., cleared under FDA 510(k) K162784 on 25 Mar 2017 and listed in FDA GUDID since 2 Aug 2021 (UDI-DI 17290112451559), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K162784

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number17290112451559 UDI-DI Date2 Aug 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162784 Date25 Mar 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162784 decided 25 Mar 2017 Active
  • FDA GUDID UDI-DI 17290112451559 listed 2 Aug 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162784
  2. Listed FDA GUDID 17290112451559

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Silk'n
Generic name
Radio-frequency skin surface treatment system
Model / Ref / Catalog
Titan AllWays, 7290112451552
Primary DI / UDI-DI
17290112451559
510(k) Number
FDA product code
PAY, OHS
GMDN term
Radio-frequency skin surface treatment system
Device class
Class II
Regulation number
878.4420, 878.4810
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Radio-frequency skin surface treatment system.

Other devices from Home Skinovations, Ltd.

See all devices from Home Skinovations, Ltd. →

Properties

  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)