# K233757: TitanPico Laser Workstation  (PICO-450)

- Pathway: 510(k) (Traditional)
- Applicant: Rhein Laser Technologies Co., Ltd.
- Decided: Apr 11, 2024 after 139 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). 288 ancestors in all.
No later device cites it as a predicate yet.
0 of 289 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153527: PicoWay Laser System, Syneron Candela Corporation (2016) Summary page 5.
- K220853: PicoWay Laser System, Candela Corporation (2022) Summary page 5.

## Indications for use
The TitanPico Laser Workstation is indicated for the following at the specified wavelength: 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. The TitanPico Laser Workstation is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

Source page: https://510kreport.com/device/K233757
Methodology: https://510kreport.com/methodology