# K171945: Discovery Pico, Discovery Pico Plus

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Jul 28, 2017 after 30 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K943450 (1995). 295 ancestors in all.
21 later devices descend from it; 1 cites it directly.
0 of 317 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163222: Discovery Pico Family, Quanta System Spa (2016) Summary page 6.

## Most influential descendants
- K172376: Discovery Pico, Discovery Pico Plus (2017), 20 descendants of its own
- K191842: Discovery Pico, Discovery Pico Plus, Discovery Pico Derm (2019), 18 descendants of its own
- K202503: Chrome (2020), 12 descendants of its own
- K213569: HOLLYWOOD SPECTRA Laser System (2022), 7 descendants of its own
- K241527: Pastelle Pro (2025), 3 descendants of its own

## Indications for use
General 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. Indications for use 1064 & 532 nm (Q-Switched, nanosecond mode) The Discovery Pico Family 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-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. 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) , also with fractional handpiece 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), also with fractional handpiece 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. 694 nm (Q-Switched) Indicated for: Tattoo removal: Suggested for blue, sky blue, black, green and violet ink Pigmented lesion removal (benign): - Cafe au lait spot - Ephalides, solar lentigo lentigines) - Becker Nevus - Ota and Ito Nevus - Nevus spilus - Mongolian spot 694 nm (non q-switch – free running mode) Intended to remove benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery. IPL 590-1200nm; 625-1200nm; 650-1200nm Indicated for permanent hair removal. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime IPL 550-1200nm; 570-1200nm Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions. IPL 400-1200nm Indicated for inflammatory acne (acne vulgaris). Integrated Skin Cooler The intended use of the integrated cooling system in the laser hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.

Source page: https://510kreport.com/device/K171945
Methodology: https://510kreport.com/methodology