# K230077: LaserME

- Pathway: 510(k) (Traditional)
- Applicant: Neauvia North America
- Decided: Jul 17, 2023 after 188 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: 18 generations back to K910422 (1992). 296 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 299 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111840: Emerge Fractional Laser, Palomar Medical Products, Inc. (2011) Summary page 4.

## Most influential descendants
- K234004: Medical diode laser systems (CHARISMA, REGAL) (2025), 1 descendant of its own
- K251699: The Botticelli (Model: Athena) (2025), 0 descendants of its own

## Indications for use
The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The LaserMe is further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.

Source page: https://510kreport.com/device/K230077
Methodology: https://510kreport.com/methodology