DEKA AGAIN PRO family

El.En S.P.A.

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

Product code GEX· 21 CFR 878.4810

View Summary PDF

Company

Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

3

Device details

FDA 510(k) registration fields

K number
K233090
Device name
DEKA AGAIN PRO family
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-09-26
Decision date
2023-10-27
Submission type
Special
Technology type
Alexandrite(AI inferred)
Clinical applications
Hair removal
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The DEKA AGAIN PRO family is a medical laser family intended for:

Alexandrite laser (755nm):
- 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 dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

Nd:YAG laser (1064nm):
- Removal of unwanted hair for stable long term or permanent hair reduction and for treatment of PFB. The laser is 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, telangiectasia, rosacea, venous 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 (such spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
- 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.
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
- Treatment of wrinkles.

Intended Use

The DEKA AGAIN PRO family is a medical laser family intended for: Alexandrite laser (755nm): - 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) included tanned skin. - Treatment of benign pigmented lesions. - Treatment of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). Nd:YAG laser (1064nm): - Removal of unwanted hair for stable long term or permanent hair reduction and for treatment of PFB. The laser 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, 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 (such spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. - 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. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Treatment of wrinkles.

Device Description

The DEKA AGAIN PRO family is a medical laser family equipped with Alexandrite 755nm laser and Nd:YAG 1064nm laser. The laser sources deliver the laser output through a lens coupled user replaceable optical fiber with a wider range of interchangeable, quick release laser handpieces with electronic spot recognition. The modifications to the device consist in a restyling of the device (new chassis, cover plastic, dimensions, weight and GUI, removal of Pulsed Light FT handpiece) and in modification to spot size ranges (new spot size available). The intended use of the modified device, as described in the labelling has not changed as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since.

Summary parsed at:2026-06-01 05:33:30 UTC

Predicate devices

1

K233090 references 1 predicate/reference device

Cited as predicate

3

3 submissions cite K233090 as a predicate