# K101152: Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family Naturalase NL810

- Pathway: 510(k) (Traditional)
- Applicant: Focus Medical, LLC
- Decided: Aug 18, 2010 after 117 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: 17 generations back to K943450 (1995). 359 ancestors in all.
No later device cites it as a predicate yet.
0 of 360 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073617: Pharaon Lipo, Osyris (2008) Summary page 1.
- K082721: Laserpro 810, 940 and 980 Diode Laser Systems, Photo Medex, Inc. (2008) Summary page 1.

## Indications for use
Natural-ase 980 Laser System is intended for laser assisted lipolysis. The NaturaL-ase 980 Laser System is intended for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, plastic surgery, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, orthopedics, pulmonology, thoracic surgery arthroscopy and podiatry.

Source page: https://510kreport.com/device/K101152
Methodology: https://510kreport.com/methodology