# K243330: LYMA Laser PRO

- Pathway: 510(k) (Traditional)
- Applicant: Lyma Life, Ltd.
- Decided: Feb 21, 2025 after 120 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- 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: 19 generations back to K943450 (1995). 126 ancestors in all.
No later device cites it as a predicate yet.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210823: LYMA Laser, Lyma Life, Ltd. (2022) Summary page 5.
- K230042: Q-Rejuvalight Pro Facewear (Model: P19-0023), Light Tree Ventures Europe B.V. (2023) Summary page 5.

## Indications for use
The LYMA Laser PRO is an Over-the-Counter (OTC) light based device intended for the use in treating face wrinkles.

Source page: https://510kreport.com/device/K243330
Methodology: https://510kreport.com/methodology