# K191685: PicoWay Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corporation
- Decided: Sep 16, 2019 after 84 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: 25 generations back to K943450 (1995). 286 ancestors in all.
20 later devices descend from it; 8 cite it directly.
0 of 307 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170597: PicoWay Laser System, Syneron Candela Corporation (2017) Summary page 5.

## Most influential descendants
- K200116: PicoSecond Nd: YAG Laser System (2020), 6 descendants of its own
- K201773: Picohi (2021), 5 descendants of its own
- K202172: StarWalker (2020), 3 descendants of its own
- K234104: PICOANDY (Q-Switched Nd:YAG Laser) (2024), 2 descendants of its own
- K253342: PICO-K (2025), 1 descendant of its own

## Indications for use
The PicoWay laser system is indicated for the following at the specified wavelength 532 nm: Removal of tattoos for Fitzpatrick skin types I‐III to treat the following tattoo colors: red, yellow and orange. 730 nm: Removal of tattoos for Fitzpatrick skin types II‐IV to treat the following tattoo colors: green and blue. 785 nm: Removal of tattoos for Fitzpatrick skin types II‐IV to treat the following tattoo colors: green and blue. 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I‐VI) to treat the following tattoo colors: black, brown, green, blue and purple. The Picoway laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I‐IV. The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II‐V. The Resolve handpieces (532 nm HE, 532nm, 1064nm) are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I‐IV The Resolve Fusion handpiece (1064 nm) is indicated for the treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I‐IV The Resolve Fusion handpiece (532 nm) is indicated for the treatment of benign pigmented lesions in Fitzpatrick Skin Types I‐IV

Source page: https://510kreport.com/device/K191685
Methodology: https://510kreport.com/methodology