Deka Luxea

El.En Electronic Engineering Spa

Country / region:Italy (IT)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

View Summary PDF

Product code

GEX
21 CFR 878.4810

Predicate devices

6

Cited as predicate

4

Device details

FDA 510(k) registration fields

K number
K192539
Device name
Deka Luxea
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2019-09-16
Decision date
2019-12-16
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removalPigment treatmentVascular treatment
Primary application
Hair removal
Classification source
AI classified

Indications for Use

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. 

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.

Intended Use

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.

Device Description

The DEKA LUXEA is a versatile medical platform that can be equipped with various types of laser and pulsed light handpieces. Thanks to its universal connector it is possible to quickly insert and deactivate the various handpieces to cover a wide spectrum of application. The available handpieces are VIVID: 808±10 nm Laser, SPARKS: 1064nm Laser, PRISMA: 1064nm Q-Switched laser, VIRIDIS: Pulsed Light handpiece 15mmx13mm with integrated 500-1200 nm filter, LILAC: Pulsed Light handpiece 48mmx13mm with interchangeable filters, RUBER: Pulsed Light handpiece 48mmx17mm with integrated 550nm filter, LAZUR: Pulsed Light handpiece 48mmx13mm with integrated 420-950 nm filter. Emission activation is either by footswitch or fingerswitch. Electrical specifications are 115-240V~, 50-60Hz, 2300VA max.

Summary parsed at:2026-06-01 05:55:59 UTC

Predicate devices

6

K192539 references 6 predicate/reference devices

Cited as predicate

4

4 submissions cite K192539 as a predicate