# K131095: Deka Synchro Repla: Y Family of Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: El.En Electronic Engineering Spa
- Decided: Dec 5, 2013 after 231 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: 17 generations back to K943450 (1995). 252 ancestors in all.
17 later devices descend from it; 1 cites 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)
- K112715: Candela Gentlemax Family of Lasers, Candela Corp. (2011). Our reading of the summary gave K122715, FDA’s number for Stellar 150 (Resmed Germany, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Candela GentleMAX family of laser systems”.
- K103288: Deka Synchro FT, El.En Electronic Engineering Spa (2011) Summary page 3.

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

## Indications for use
The DEKA Synchro Repla:Y family of laser systems is indicated for: 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 I - VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. Photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). 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 1-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacca, 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 spats), cafe au lait macules, sebarrheic 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 handojece: Permanent hair reduction, photocoagulation of vascular lesions, phototherniolysis 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- l200nm | - | Skin Typesl,il | Skin Types L. 11 520- l200nm | | Skin TypelHI | Skin Typetll | Skin Types I I 550- l200rnn | Skin Types1, 11- | | | Skin Type 111 600- I2013mn | Skin Type Mn- | | | 650- l200nnx | Skin Type IV | -- | | Skin TyeI

Source page: https://510kreport.com/device/K131095
Methodology: https://510kreport.com/methodology