# K102639: SL3

- Pathway: 510(k) (Special)
- Applicant: Discus Dental, LLC
- Decided: Dec 1, 2010 after 78 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K922901 (1992). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091796: Softlase Pro, Ortholase and Hygienelase, Zap Lasers, LLC (2009) Summary page 2.
- K081214: Styla Microlaser and Stylaortho, Zap Lasers, LLC (2008) Summary page 2.

## Most influential descendants
- K141838: Sol Portable Diode Laser Unit (with Wireless Foot Control) (2014), 0 descendants of its own

## Recalls of this device
- Jul 21, 2011 · Class II · Z-1186-2013: The firm is initiating this recall of the SL3 Soft Tissue Laser equipped with a fiber optic Unifiber system which contains a fragile glass filament because the fiber broke near the hand piece.

## Indications for use
The SL3 laser is to provide the ability to perform intraoral soft tissuedental, general, oral maxilla-facial and cosmetic surgery. The SL3 laser is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system. The device will be used in the following areas: general and cosmetic dentistry, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, genecology, urology, opthamology and pulmonary surgery. The following are the oralpharngeal indications for use for which the device will be marketed: -Excision and Incision Biopsies -Hemostatic assistance -Treatment of Apthous Ulcers -Frenectomy -Frenotomy -Gingival Incision and Excision -Gingivectomy -Gingivopla sty -Incising and Draining of Abscesses -Operculectomy -Oral Papillectomry -Removal of Fibromas -Soft Tissue Crown Lengthening -Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) -Tissue retraction for Impression -VestibulIoplasty -Light activation of bleaching materials for teeth whitening -Laser-assisted bleaching/whitening of teeth

Source page: https://510kreport.com/device/K102639
Methodology: https://510kreport.com/methodology