# K082039: Synchro HP Platform

- Pathway: 510(k) (Traditional)
- Applicant: El.En Electronic Engineering Spa
- Decided: Mar 20, 2009 after 245 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: 15 generations back to K943450 (1995). 240 ancestors in all.
19 later devices descend from it; 1 cites it directly.
0 of 260 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033172: Candela Gentleyag Family of Laser Systems, Candela Corp. (2003) Summary page 1.
- K051442: Photosilk Plus Pulsed Light System and Laser Attachment, Cynosure, Inc. (2006) Summary page 1.
- K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008) 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
Nd:YAG Laser (1064 nm): 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; Er:YAG Laser attachment (2940 nm): skin resurfacing and incision, excision, ablation or vaporization of soft bodily tissues. Q-switched Nd:YAG Laser attachment (1064 nm): removal of dark tattoos and treatment of benign pigmented lesions. Pulsed Light attachments (400, 500, 520, 550, 650 to 950 nm): permanent hair reduction, treatment of benign cutaneous vascular lesions including facial and leg veins, benign pigmented epidermal lesions, moderate inflammatory acne vulgaris. Different wavelength ranges of Pulsed Light attachments are indicated for the various treatments and skin types, as indicated in the following table: 400 - 950 nm: Moderate Inflammatory Acne Vulgaris (Skin Types I, II, III, IV) 500 - 950 nm: Benign Cutaneous Vascular Lesions (Skin Types I, II) 520 - 950 nm: Benign Cutaneous Vascular Lesions (Skin Type III); Benign Pigmented Epidermal Lesions (Skin Types I, II); Permanent Hair Reduction (Skin Types I, II) 550 - 950 nm: Benign Pigmented Epidermal Lesions (Skin Types III, IV); Permanent Hair Reduction (Skin Types I, II, III) 650-950 nm: Permanent Hair Reduction (Skin Type IV)

Source page: https://510kreport.com/device/K082039
Methodology: https://510kreport.com/methodology