# K071815: Noveon, Model LS1100-01-0968

- Pathway: 510(k) (Traditional)
- Applicant: Nomir Medical Technologies, Inc.
- Decided: Nov 28, 2007 after 149 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: 3 generations back to K912538 (1991). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032864: Ceralas D 810 Diode Laser System, Model D15, Biolitec, Inc. (2004) Summary page 1.
- K040294: Laserpro Diode Laser Systems, Models 810, 940 & 980, Photo Medex, Inc. (2004) Summary page 1.
- K060114: Vectra Laser System, Xintec Corporation, Dba, (2006) Summary page 1.
- K062363: BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NM, B&W Tek, Inc. (2007) Summary page 1.
- K060304: Photex Diode Laser Series, Models 980, 810 and 940, Biotex, Inc. (2006) Summary page 1.
- K061436: Palomar Q-Yag 5 ND:Yag Laser System, Palomar Medical Technologies, Inc. (2006) Summary page 1.
- K011677: Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag Laser, Continuum Electro-Optics, Inc. (2001)

## Indications for use
The NoveonTM (Model LS1 100-01-0968) delivers continuous wave laser light in the contact or non-contact mode during surgical procedures of the skin, subcutaneous tissues and nasal passages in dermatology, plastic surgery, podiatry and otolaryngology. The device is indicated for use in applications requiring incision, excision, vaporization, hemostasis, or coagulation of soft tissue.

Source page: https://510kreport.com/device/K071815
Methodology: https://510kreport.com/methodology