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

4

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K240983
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
2024-04-10
Decision date
2025-06-06
Submission type
Traditional
Technology type
Q-Switched(AI inferred)
Clinical applications
Pigment treatmentVascular treatmentHair removalSurgical cutting
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 angioma
  - 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, venous 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 r

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. The device 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.

Device Description

The Discovery Pico family includes medical laser devices for dermatology and aesthetic medicine. It is used by health care professionals (dermatologists) in professional healthcare environments for the treatment of different skin conditions and hair removal. Discovery Pico family includes the following models: Discovery Pico, Discovery Pico Plus, Discovery Pico Derm. The device is equipped with a display with a graphical user interface (GUI) for user-device interaction. Laser beam is delivered through an articulated arm with handpiece connected at its end and can be activated with a footswitch. Four types of handpieces are available: Round (diameter): 2 to 12 mm; Square (side): 2, 3, 4, 5, 7 mm; Microbeam/fractional handpieces: 8, 9 mm; Rosso handpiece. The device can be divided into four main sections: Power electronics, Control electronics, Cooling system, Optical bench.

Summary parsed at:2026-06-01 05:21:02 UTC

Predicate devices

4

K240983 references 4 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K240983 as a predicate