# K243630: Medical Laser System Incanto / Evoline Platinum /Evoline

- Pathway: 510(k) (Traditional)
- Applicant: Solar LS Cjsc
- Decided: Mar 21, 2025 after 116 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: 20 generations back to K943450 (1995). 287 ancestors in all.
No later device cites it as a predicate yet.
0 of 288 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233090: DEKA AGAIN PRO family, El.En S.P.A. (2023) Summary page 5.
- K122493: Genesisplus, Cutera, Inc. (2013) Summary page 5.

## Indications for use
Indications for use: 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) 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 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 (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. - Temporary increase of clear nail in patients with onychomycosis (e.g.; dermatophytes, Trichophyton rubrumn and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

Source page: https://510kreport.com/device/K243630
Methodology: https://510kreport.com/methodology