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Silk'n Relief / HeatLux Pro II

by Home Skinovations, Ltd.

Silk'n Relief / HeatLux Pro II (7290015418904) is a medium-wave diathermy treatment system generator (FDA Class II) made by Home Skinovations, Ltd., cleared under FDA 510(k) K152087 on 29 Jul 2016 and listed in FDA GUDID since 13 Dec 2016 (UDI-DI 17290015418901), 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) K152087

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 Number17290015418901 UDI-DI Date13 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152087 Date29 Jul 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152087 decided 29 Jul 2016 Active
  • FDA GUDID UDI-DI 17290015418901 listed 13 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K152087
  2. Listed FDA GUDID 17290015418901

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  • Withdrawn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
Medium-wave diathermy treatment system generator
Model / Ref / Catalog
Relief / HeatLux Pro II, 7290015418904
Primary DI / UDI-DI
17290015418901
510(k) Number
FDA product code
ILY, GEI
GMDN term
Medium-wave diathermy treatment system generator
Device class
Class II
Regulation number
890.5500, 878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medium-wave diathermy treatment system generator

Cleared under the same submission (K152087)

Similar devices

Other devices filed under FDA product code ILY (Lamp, Infrared, Therapeutic Heating).

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)