# K220853: PicoWay Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corporation
- Decided: Oct 13, 2022 after 204 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). 287 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 289 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.

## Most influential descendants
- K233757: TitanPico Laser Workstation  (PICO-450) (2024), 0 descendants 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 I-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 rm: Removal of tattoos for all Fitzpatrick Skin Types 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 11-V and for treatment of Melasma for Fitzpatrick Skin Types I-IV. The Resolve handpieces (532 mn HE, 532 rm, and 1064 nm) are also indicated for the treatment of wrinkles in Fitzpatrick Skin Types I-IV. The Resolve Fusion handpiece (532 nm) is indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I- IV. The PicoWay laser system is indicated for the following at the specified wavelengths: 532 nm: * Treatment of Melasma for Fitzpatrick Skin Types I-IV. * Treatment of caf6 au lait macules (CALMs) for Fitzpatrick Skin Types I-IV. * Treatment of Lentigines for Fitzpatrick Skin Types I-IV. 730 nm: * Treatment of Lentigines for Fitzpatrick Skin Types I-IV. 1064 nrm: * Treatment of Melasma for Fitzpatrick Skin Types I-IV. * Treatment ofNevus of Ota for Fitzpatrick Skin Types III-IV.

Source page: https://510kreport.com/device/K220853
Methodology: https://510kreport.com/methodology