# K103288: Deka Synchro FT

- Pathway: 510(k) (Traditional)
- Applicant: El.En Electronic Engineering Spa
- Decided: Jan 31, 2011 after 84 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: 16 generations back to K943450 (1995). 243 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 262 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082039: Synchro HP Platform, El.En Electronic Engineering Spa (2009) Summary page 1.
- K082040: Minisilk FT, El.En Electronic Engineering Spa (2009) Summary page 1.

## Most influential descendants
- 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
- K181486: DEKA Motus AY (2018), 2 descendants of its own

## Indications for use
The Deka Synchro FT is indicated for the following treatments: Nd:YAG laser: Removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions. Pulsed light attachment: Permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions. Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types, as indicated in the following table: Pulsed light wavelength range | Hair reduction | Vascular lesions | Blood vessels | Pigmented lesions 500 - 1200nm | -Skin Types 1, 11 | | Skin Types 1, 11 | 520 - l200n | | Skin Type IlI | Skin Type Ill | Skin Types 1, 11 550 - l200nm | Skin Types 1,11 | | | Skin Type IIl 600 - l200nm | Skin Type III | | | 650 - l200nm | Skin Type IV | | -Skin Type IV |

Source page: https://510kreport.com/device/K103288
Methodology: https://510kreport.com/methodology