# K173700: PICOPLUS Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: Jun 19, 2018 after 197 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: 26 generations back to K943450 (1995). 314 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 322 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172077: Cutera enlighten III Laser System, Cutera, Inc. (2017) Summary page 6.
- K163222: Discovery Pico Family, Quanta System Spa (2016) Summary page 6.

## Most influential descendants
- K200116: PicoSecond Nd: YAG Laser System (2020), 6 descendants of its own
- K220268: Picosecond Laser System (Model PS10-A and PS10-B) (2022), 1 descendant of its own
- K260017: Picosecond Nd:YAG Laser Systems (Model: HS-298) (2026), 0 descendants of its own
- K252345: Picosecond Laser Device (PF131-BI) (2025), 0 descendants of its own
- K252447: Picosecond laser device (BMPS4) (2025), 0 descendants of its own

## Indications for use
The PICOPLUS Laser System is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery as follows: The 1064 nm wavelength and 450 pico-second pulse width of the PICOPLUS system is indicated for: » Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple. * Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. The 532 nm wavelength and 450 pico-second pulse width of the PICOPLUS system is indicated for: » Removal of tattoos for Fitzpatrick skin types I-111 with the following tattoo colors: red, yellow and orange. * Treatment of benign pigmented lesions removal for Fitzpatrick Skin Types [-IV. The 1064 nm wavelength and nanosecond pulse width of the PICOPLUS system is indicated for: * Treatment of benign pigmented lesions on Fitzpatrick skin type I-VI * Removal of dark and multi-colored tattoos containing dark colored tattoo inks on Fitzpatrick skin types 1-VI The 532 nm wavelength and nanosecond pulse width of the PICOPLUS system is indicated for: * Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV » Removal of lighter colored tattoo inks, including red and yellow inks, on Fitzpatrick skin types I-111

Source page: https://510kreport.com/device/K173700
Methodology: https://510kreport.com/methodology