# K110079: Spphine Plus STM 3W Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: Den-Mat Holdings, LLC
- Decided: Feb 10, 2011 after 30 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: 7 generations back to K922901 (1992). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062258: Genesis Diode Laser, Ivoclar Vivadent, Inc. (2007) Summary page 1.
- K081214: Styla Microlaser and Stylaortho, Zap Lasers, LLC (2008) Summary page 1.
- K050453: Odyssey 2.4G, Denlaser Elite, Model 002-00050, Ivoclar Vivadent, Inc. (2005) Summary page 1.

## Indications for use
The Sapphire Plus SIM 3W Diode Laser is intended for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fibre optic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; frenectomy; frenotomy; gingival incision and excision; gingivectomy; gingivoplasty; incising and draining abscesses; operculectomy; oral papilleetomy; removal of fibromas; soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; and vestibuloplasty.

Source page: https://510kreport.com/device/K110079
Methodology: https://510kreport.com/methodology