# K150516: Deka Synchro Repla:Y Family of Laser Systems

- Pathway: 510(k) (Special)
- Applicant: El.En Electronic Engineering Spa
- Decided: Apr 13, 2015 after 42 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: 18 generations back to K943450 (1995). 253 ancestors in all.
16 later devices descend from it; 6 cite it directly.
0 of 270 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131095: Deka Synchro Repla: Y Family of Laser Systems, El.En Electronic Engineering Spa (2013) Summary page 5.

## Most influential descendants
- 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
- K211821: DEKA Motus AZ (2021), 1 descendant of its own
- K193426: Elite iQ (2020), 1 descendant of its own

## Indications for use
755mn laser: Temporary hair reduction. Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick 1 — VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. Photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangicctasias). 1064nm laser: Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions. such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos, (age spots). solar lentigos (sun spots), cafe au lait macules, scborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. Pulsed light FT handpiece: 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 Hair reduction Vascular lesions Blood vessels Pigmented lesions Wavelength range 500-1200nm - Skin Types I, 11 Skin Types I, 11 - 520-1200nm - Skin Type I Skin Type I Skin Types LTI 550-1200nm Skin Types I, 11 - - Skin Type 11l 600-1200nm Skin Type I11 - - - 650-1200nm Skin Type IV - - Skin Type IV

Source page: https://510kreport.com/device/K150516
Methodology: https://510kreport.com/methodology