DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS

El.En Electronic Engineering Spa

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

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

6

Device details

FDA 510(k) registration fields

K number
K150516
Device name
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2015-03-02
Decision date
2015-04-13
Submission type
Special
Technology type
Alexandrite(AI inferred)
Clinical applications
Hair removalPigment treatmentVascular treatmentSkin resurfacing
Primary application
Hair removal
Classification source
AI classified

Indications for Use

755nm 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 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, seborrheic 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.

Intended 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 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 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, seborrheic 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.

Device Description

The Deka Synchro Repla:Y family of lasers is a platform which can be equipped with two separate solid state laser heads (755nm and 1064nm) and a pulsed light handpiece (FT handpiece). The two laser heads can only be activated separately and they deliver the laser output through the same single laser delivery system, consisting of a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition. The FT handpiece delivers the pulsed light to the treatment area by means of a sapphire lightguide; it is provided with has an integrated skin cooling system and is equipped with five different emission spectra interchangeable filters. The system allows to switch from one of the three available sources to the other by pressing a key on touch panel. Handpiece activation is either by footswitch or fingerswitch. The modifications to the device are two laser handpieces, allowing for a larger treatment area, 22mm and 24mm, and a change of maximum pulse repetition rate for some intermediate settings for the Nd:YAG laser source. The device hardware did not require any modification to support the new features. Minor changes to the software have been made in order to manage the new handpieces and the modified intermediate settings for the Nd:YAG laser source. The intended use of the modified device, as described in the labeling, has not changed as a result of the modifications.

Summary parsed at:2026-06-01 06:10:56 UTC

Predicate devices

1

K150516 references 1 predicate/reference device

Cited as predicate

6

6 submissions cite K150516 as a predicate