# K200116: PicoSecond Nd: YAG Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Apolo Medical Technology Co., Ltd.
- Decided: May 28, 2020 after 128 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: 27 generations back to K943450 (1995). 316 ancestors in all.
6 later devices descend from it; 6 cite it directly.
0 of 323 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191685: PicoWay Laser System, Candela Corporation (2019) Summary page 5.
- K173700: PICOPLUS Laser System, Lutronic Corporation (2018) Summary page 5.

## Most influential descendants
- 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
- K250041: Medical Picosecond ND: YAG Laser System (PZ-6) (2025), 0 descendants of its own

## Indications for use
The PicoSecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows: 1064nm wavelength: - 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. 532nm wavelength: - Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

Source page: https://510kreport.com/device/K200116
Methodology: https://510kreport.com/methodology