# K121435: Silkn Blue

- Pathway: 510(k) (Traditional)
- Applicant: Home Skinovations, Ltd.
- Decided: Feb 22, 2013 after 284 days
- Product code: OLP (Over-The-Counter Powered Light Based Laser For Acne)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K943450 (1995). 96 ancestors in all.
125 later devices descend from it; 8 cite it directly.
0 of 222 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060653: Thermaclear, Dermacare, Inc. (2006) Summary page 1.
- K093963: Quasar Blue Light Therapy System, Silver Bay, LLC (2010) Summary page 1.
- K080591: Tanda Skincare System, Model: Ptscs, Pharos Life Corporation (2008) Summary page 1.
- K081307: Omnilux Clear-U, Photo Therapeutics, Inc. (2009) Summary page 1.

## Most influential descendants
- K131461: Lightstim for Acne/ Lightstim for Acne Mini (2014), 81 descendants of its own
- K162098: LED Phototherapy Device (2017), 75 descendants of its own
- K171821: 2 Face / Face Evolution (2018), 58 descendants of its own
- K142246: LightStim for Acne/ LightStim for Acne Mini (2015), 55 descendants of its own
- K172555: Sapphire, Elevare Sapphire (2018), 52 descendants of its own

## Indications for use
The Silkn Blue is indicated as an over the counter phototherapy device for the treatment of mild to moderate acne.

Source page: https://510kreport.com/device/K121435
Methodology: https://510kreport.com/methodology