# K260489: LASEmaR 1500

- Pathway: 510(k) (Traditional)
- Applicant: Eufoton S.R.L.
- Decided: May 29, 2026 after 105 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: 1 generation back to K092860 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092860: Lasemar 800, 1000, 1500, Eufoton S.R.L. (2010) Summary page 5.

## Indications for use
The LASEmaR 1500 laser system (and the fiber delivery systems and accessories) is indicated for surgical applications requiring vaporization, incision, excision, ablation, cutting, and hemostasis or coagulation (in combination with endoscopy equipment) for medical specialties including: Plastic/Aesthetic Medicine, ENT, Gynecology and Neurosurgery and Laser assisted Lypolysis.

Source page: https://510kreport.com/device/K260489
Methodology: https://510kreport.com/methodology