Medical Laser System Incanto / Evoline Platinum /Evoline

Solar LS Cjsc

Country / region:Belarus (BY)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Belarus (BY)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K243630
Device name
Medical Laser System Incanto / Evoline Platinum /Evoline
Country / region
Belarus(BY)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-11-25
Decision date
2025-03-21
Submission type
Traditional
Technology type
Alexandrite(AI inferred)
Clinical applications
Hair removal
Primary application
Hair removal
Classification source
AI classified

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) 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, teleangiectasia, 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.
- Temporary increase of clear nail in patients with onychomycosis (e.g.; dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

Intended 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.)

Device Description

The laser systems (modifications INCANTO, EVOLINE, EVOLINE PLATINUM), provides 1064nm Nd:YAG radiation and 755nm Alexandrite radiation. Availability of two wavelengths (1064nm and 755nm) in one laser system allows to select the most optimal laser radiation exposure type for different skin types.

Summary parsed at:2026-06-01 05:21:42 UTC

Predicate devices

2

K243630 references 2 predicate/reference devices

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0

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