# K110301: Silk'n FX

- Pathway: 510(k) (Traditional)
- Applicant: Home Skinovations, Ltd.
- Decided: Aug 19, 2011 after 198 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- 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: 11 generations back to K943450 (1995). 91 ancestors in all.
66 later devices descend from it; 4 cite it directly.
0 of 158 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072459: Omnilux New-U, Photo Therapeutics, Inc. (2008) Summary page 1.

## Most influential descendants
- K152332: Perfectio LED infrared device (2016), 61 descendants of its own
- K162489: RED Light Device (2017), 55 descendants of its own
- K212155: TheraFace LED (2021), 42 descendants of its own
- K223544: LED light therapy mask (FM-01, FM-02, FM-03) (2023), 39 descendants of its own
- K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (2024), 21 descendants of its own

## Indications for use
Silkn FX is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Source page: https://510kreport.com/device/K110301
Methodology: https://510kreport.com/methodology