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Silkn Blue

by Home Skinovations, Ltd.

510(k) K121435

Silkn Blue is a medical device (FDA Class II; FDA product code OLP, Over-The-Counter Powered Light Based Laser For Acne) made by Home Skinovations, Ltd., cleared under FDA 510(k) K121435 on 22 Feb 2013, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121435 Date22 Feb 2013ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OLP
FDA applicant
Home Skinovations , Ltd.
Device class
Class II
Regulation
21 CFR Part 878.4810
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K121435

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K121435
UDI-DISize and differences
Silk'n Blue
Home Skinovations, Ltd.
7290015418621 / Blue17290015418628 —On the market

Similar devices

Other devices filed under FDA product code OLP (Over-The-Counter Powered Light Based Laser For Acne).

Other devices from Home Skinovations, Ltd.

See all devices from Home Skinovations, Ltd. →