EVO platform

Quanta System Spa

Country / region:Italy (IT)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

0
Cited in this 510(k)

Cited as predicate

4

Device details

FDA 510(k) registration fields

K number
K160368
Device name
EVO platform
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-02-09
Decision date
2016-04-05
Submission type
Special
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, hemaongiomae, 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)
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 an

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. Indicated for treatment of vascular lesions, pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology.

Device Description

The EVO Platform is a laser device that operates at multiple wavelengths (1064 nm and 532 nm) and modes (Q-Switched, non Q-Switched, picosecond, and pulsed) for various applications including tattoo removal, treatment of vascular and pigmented lesions, hair removal, and skin resurfacing procedures. It is designed for use in dermatology and plastic surgery, providing photocoagulation and hemostasis of soft tissue.

Summary parsed at:2026-06-01 06:05:53 UTC

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