Manufacturer
Quanta System SpaEVO platform
Country / Region:Italy (IT)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K152012
- 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
- 2015-07-21
- Decision date
- 2015-12-08
- Submission type
- Traditional
- Technology type
- Q-Switched(AI inferred)
- Clinical applications
- Vascular treatmentPigment treatmentHair removalSurgical cutting
- 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. 532 nm (picosecond mode) - Indicated for the removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. - Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV. 1064 nm (picosecond mode) - Indicated for the removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. - Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV. 1064 nm (pulsed) - Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign
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 family that includes Q-Switched and/or Pulsed laser sources, emitting at one or more of the following wavelengths: 532 nm, 1064 nm, 1320 nm (Nd:YAG laser), 694 nm (Ruby laser), or 755 nm (Alexandrite laser). The EVO Platform systems, through the special universal Twain connector, can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm. The optical delivery system is an articulated arm with fixed handpieces for Q-switched sources and an optical fiber with focusing handpieces for pulsed sources. The optical delivery system for the IPL system is a handpiece (Twain IPL) with fixed or interchangeable light filters at different wavelengths. All the models belonging to the EVO platform have the same components and the same control software. The only difference between different models is the optical bench that depends on the sources installed. The EVO Platform is controlled via a touch screen display housed in the front of the device. Emission is triggered by means of a footswitch.
Summary parsed at:2026-06-01 06:11:27 UTC
Predicate devices
7Cited as predicate
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