# K213889: PicoStar

- Pathway: 510(k) (Traditional)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: Apr 22, 2022 after 130 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). 297 ancestors in all.
No later device cites it as a predicate yet.
0 of 298 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172376: Discovery Pico, Discovery Pico Plus, Quanta System Spa (2017) Summary page 5.

## Indications for use
The PicoStar 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. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-III. 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV. Only with microspot handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV. Only with microspot handpiece, indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.

Source page: https://510kreport.com/device/K213889
Methodology: https://510kreport.com/methodology