# K082040: Minisilk FT

- Pathway: 510(k) (Traditional)
- Applicant: El.En Electronic Engineering Spa
- Decided: Aug 27, 2009 after 405 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- 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: 1 generation back to K031258 (2003). 1 ancestor in all.
19 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031258: Cynosure Photolight PL, Cynosure, Inc. (2003) Summary page 1.

## Most influential descendants
- K103288: Deka Synchro FT (2011), 18 descendants of its own
- K131095: Deka Synchro Repla: Y Family of Laser Systems (2013), 17 descendants of its own
- K150516: Deka Synchro Repla:Y Family of Laser Systems (2015), 16 descendants of its own
- K192539: Deka Luxea (2019), 4 descendants of its own
- K233090: DEKA AGAIN PRO family (2023), 2 descendants of its own

## Indications for use
The MinisilkFT pulsed light device is indicated for permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels and treatment of benign pigmented lesions.

Source page: https://510kreport.com/device/K082040
Methodology: https://510kreport.com/methodology