# K242534: HandPICO Fractional Laser Handpiece Tip

- Pathway: 510(k) (Traditional)
- Applicant: Vydence Medical
- Decided: Dec 20, 2024 after 116 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). 313 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 315 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191842: Discovery Pico, Discovery Pico Plus, Discovery Pico Derm, Quanta System Spa (2019) Summary page 5.
- K191685: PicoWay Laser System, Candela Corporation (2019) Summary page 5.

## Most influential descendants
- K252753: Vydence Family of Lasers (2026), 0 descendants of its own

## Indications for use
The handPICO® Fraction Laser Handpiece Tip, when used with the Etherea-MX and Zye lasers at 1064 nm in picosecond mode, is indicated for: • Removal of tattoos on all skin types (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. • Treatment of acne scars in Fitzpatrick Skin Types II-V. • Treatment of wrinkles in Fitzpatrick Skin Types I-IV.

Source page: https://510kreport.com/device/K242534
Methodology: https://510kreport.com/methodology