# K092860: Lasemar 800, 1000, 1500

- Pathway: 510(k) (Traditional)
- Applicant: Eufoton S.R.L.
- Decided: Jul 16, 2010 after 302 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K260489: LASEmaR 1500 (2026), 0 descendants of its own

## Indications for use
The Lasemar 800, Lasemar 10001 Lasemar 1500 (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgey Ophthalmology, Orthopedics, Podiatry. Arthroscopy, Spinal Surgery, Gryneooy Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck)ENT andclo Radiology, Endovascular coagulation, Oral Surgery, Dental procedures and Laser Assisted Lipolysis.

Source page: https://510kreport.com/device/K092860
Methodology: https://510kreport.com/methodology