# K233090: DEKA AGAIN PRO family

- Pathway: 510(k) (Special)
- Applicant: El.En S.P.A.
- Decided: Oct 27, 2023 after 31 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: 19 generations back to K943450 (1995). 254 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 257 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150516: Deka Synchro Repla:Y Family of Laser Systems, El.En Electronic Engineering Spa (2015) Summary page 7.

## Most influential descendants
- K243630: Medical Laser System Incanto / Evoline Platinum /Evoline (2025), 0 descendants of its own
- K240396: Elite iQ PRO (M122K1) (2024), 0 descendants of its own

## 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 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 Fitzapatrick 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 od 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.

Source page: https://510kreport.com/device/K233090
Methodology: https://510kreport.com/methodology