Manufacturer
Quanta System SpaEVO Platform
Country / Region:Italy (IT)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Device details
FDA 510(k) registration fields
- K number
- K192160
- Device name
- EVO Platform
- Company
- Quanta System Spa
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-08-09
- Decision date
- 2019-09-06
- Submission type
- Special
- Technology type
- Q-Switched(AI inferred)
- Clinical applications
- Vascular treatmentPigment treatmentHair removal
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
The EVO Platform is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows. Indications for use 1064 & 532 nm (Q-Switched, nanosecond mode) The EVO Platform is intended for treatment of vascular lesions, pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of: 532 nm (Q-Switched, nanosecond mode) Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos Treatment of vascular lesions including, but not limited to: - port wine birthmarks - telangiectasias - spider angiomaa - Cherry angioma - Spider nevi Treatment of benign pigmented lesions including, but not limited to: - cafe-au-lait birthmarks - Ephalides, solar lentigines - senile lentigines - Becker's nevi - freckles - common nevi - nevus spilus - Ota Nevus Treatment of seborrheic keratosis Treatment of post inflammatory hyperpigmentation Skin resurfacing procedures for the treatment of acne scars and wrinkles. 1064 nm (Q-Switched, nanosecond mode) Removal of dark ink (black, blue and brown) tattoos Removal of benign pigmented lesions including; - nevus of Ota - Café au lait spot - Ephalides, solar lentigo (lentigines) - Becker Nevus - Nevus spilus Treatment of common nevi Removal or lightening of unwanted hair Skin resurfacing procedures for the treatment of acne scars and wrinkles 1064 nm (non Q-Switched – free running mode) Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for 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, hemangiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Treatment of wrinkles. Treatment of mild to moderate inflammatory acne vulgaris. 1064 nm (pulsed) Dermatology/Plastic Surgery: Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The laser is also indicated for the treatment of facial wrinkles. Additionally, the laser is indicated for the treatme
Intended Use
The EVO Platform is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows. The EVO Platform is intended for treatment of vascular lesions, pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of: Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos; Treatment of vascular lesions including, but not limited to: port wine birthmarks, telangiectasias, spider angiomaa, Cherry angioma, Spider nevi; Treatment of benign pigmented lesions including, but not limited to: cafe-au-Iait birthmarks, Ephalides, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus, Ota Nevus; Treatment of seborrheic keratosis; Treatment of post inflammatory hyperpigmentation; Skin resurfacing procedures for the treatment of acne scars and wrinkles.
Device Description
The EVO Platform is a laser device that operates at wavelengths of 1064 & 532 nm in Q-Switched, nanosecond mode and 1064 nm in non Q-Switched – free running mode. It is intended for various dermatological and surgical applications including the removal of tattoos, treatment of vascular and pigmented lesions, hair removal, and skin resurfacing. The device is indicated for all skin types, Fitzpatrick I-VI, including tanned skin. It also features an integrated cooling system to provide cooling of the skin prior to laser treatment, reducing pain during treatment and allowing for the use of higher fluences.
Summary parsed at:2026-06-01 05:55:45 UTC
Predicate devices
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Cited as predicate
1Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
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