# K192539: Deka Luxea

- Pathway: 510(k) (Traditional)
- Applicant: El.En Electronic Engineering Spa
- Decided: Dec 16, 2019 after 91 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: 22 generations back to K943450 (1995). 549 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 554 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152714: Quanta Forte, Quanta System Spa (2015) Summary page 5.
- K103288: Deka Synchro FT, El.En Electronic Engineering Spa (2011) Summary page 5.
- K142860: Lumenis M22 System, Lumenis, Ltd. (2015) Summary page 5.
- K150516: Deka Synchro Repla:Y Family of Laser Systems, El.En Electronic Engineering Spa (2015) Summary page 5.
- K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008) Summary page 5.
- K020941: Palomar Luxg Handpiece, Palomar (2002) Summary page 5.

## Most influential descendants
- K234057: Nirvana (2024), 0 descendants of its own
- K220794: 10PL (2022), 0 descendants of its own
- K212790: XLase Plus (2022), 0 descendants of its own
- K200616: E>EyeC (2020), 0 descendants of its own

## Indications for use
VIVID LASER handpiece: Indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction. 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 SPARKS LASER handpiece : Indicated for removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of benign pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions. PRISMA LASER handpiece: Indicated for removal of dark tattoos and treatment of benign pigmented lesions. RUBER, LILAC Pulsed Light handpieces: Permanent hair reduction. photocoagulation of benign 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 Benign Blood vessels Benign Wavelength range Vascular lesions Pigmented lesions 500-1200nm - Skin Types I, II Skin Types I, II - 520-1200nm - SkinType III Skin Type III Skin Types I, II 550-1200nm Skin Types I, II - - Skin Type III 600-1200nm Skin Type III - - - 650-1200nm Skin Type IV - - Skin Type IV LAZUR Pulsed Light handpiece: The handpiece (with and without contact-cooling) is indicated for: -The treatment of moderate inflammatory acne vulgaris. -The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). -The treatment of benign cutaneous lesions including warts, scars and striae. -The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. - Use on all skin types (Fitzpatrick I-VI). VIRIDIS Pulsed Light handpiece: Photocoagulation of benign dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and-leg veins), and the treatment of benign pigmented lesions.

Source page: https://510kreport.com/device/K192539
Methodology: https://510kreport.com/methodology