# K072906: SILK'N

- Pathway: 510(k) (Traditional)
- Applicant: Home Skinovations, Ltd.
- Decided: Jan 23, 2008 after 104 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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: 8 generations back to K950019 (1995). 22 ancestors in all.
169 later devices descend from it; 1 cites it directly.
0 of 192 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060839: Abc Hair Removal System, Palomar Medical Technologies, Inc. (2006) Summary page 1.
- K020856: Spatouch Photoepilation System, Radiancy (Israel), Ltd. (2002) Summary page 1.

## Most influential descendants
- K082298: Flash N' GO (2008), 168 descendants of its own
- K090820: Tria Hair Removal Laser System (2009), 167 descendants of its own
- K103184: Silk'n Flash N GO (2010), 148 descendants of its own
- K103560: Shaser Ipl Hair Removal System (2011), 140 descendants of its own
- K120080: Shaser HRS2 Hair Removal System (2012), 135 descendants of its own

## Indications for use
The Silk'n is intended for removal of unwanted hair by using selective photothermal treatment. The device is generally indicated for dermatological use. The Silk'n is specifically indicated for patient removal of unwanted hair by using selective photothremal treatment under the direction of a physician, after training by a healthcare professional.

Source page: https://510kreport.com/device/K072906
Methodology: https://510kreport.com/methodology