Discovery Pico, Discovery Pico Plus, Discovery Pico Derm

Quanta System Spa

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

Product code GEX· 21 CFR 878.4810

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Company

Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

4

Device details

FDA 510(k) registration fields

K number
K191842
Device name
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2019-07-09
Decision date
2019-09-17
Submission type
Traditional
Technology type
Q-Switched(AI inferred)
Clinical applications
Surgical cuttingSkin resurfacingPigment treatment
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The Discovery Pico Family 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 Discovery Pico Family is intended for treatment of benign vascular lesions, benign 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), including microbeam handpieces:
Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
Treatment of benign 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), including microbeam handpieces:
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 benign pigmented and benign 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), also with fractional and microbeam handpieces:
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.
Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV
1064 nm (picosecond mode), also with fractional and microbeam handpieces:
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.
Only with fractional handpiece, indicate

Intended Use

The Discovery Pico Family 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 Discovery Pico Family is intended for treatment of benign vascular lesions, benign 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 benign 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 Discovery Pico Family 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, 694 nm (Ruby laser). The Discovery Pico Family 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. It can also be connected to Er:YAG handpieces cleared under K173002. The optical delivery system is an articulated arm with fixed handpieces. 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 Discovery Pico Family have the same components and the same controlling software. The only difference between different models is the optical bench that depends on the sources installed. The Discovery Pico Family 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 05:55:40 UTC

Predicate devices

2

K191842 references 2 predicate/reference devices

Cited as predicate

4

4 submissions cite K191842 as a predicate