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Silk'n Flash & Go Express

by Home Skinovations, Ltd.

Silk'n Flash & Go Express (7290015418867) is a cosmetic red-light phototherapy system (FDA Class II) made by Home Skinovations, Ltd., cleared under FDA 510(k) K141242 on 17 Oct 2014 and listed in FDA GUDID since 15 Aug 2016 (UDI-DI 17290015418864), 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) K141242

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 Number17290015418864 UDI-DI Date15 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141242 Date17 Oct 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141242 decided 17 Oct 2014 Active
  • FDA GUDID UDI-DI 17290015418864 listed 15 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K141242
  2. Listed FDA GUDID 17290015418864

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  • Withdrawn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
Cosmetic red-light phototherapy system, home-use
Model / Ref / Catalog
Flash & Go Express, 7290015418867
Primary DI / UDI-DI
17290015418864
510(k) Number
FDA product code
ONF, OHT
GMDN term
Cosmetic red-light phototherapy system, home-use
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cosmetic red-light phototherapy system, home-use

Cleared under the same submission (K141242)

and 8 more cleared under K141242

Similar devices

Other devices filed under FDA product code ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect).

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)