# K021227: Softlase G2-Surgical Diode Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Zap Lasers, LLC
- Decided: Jun 26, 2002 after 69 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: 1 generation back to K003385 (2001). 2 ancestors in all.
56 later devices descend from it; 4 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003440: Softlase - Surgical Diode Laser System, Zap Lasers, Inc. (2001) Summary page 2.
- K003385: Twilite, Twilite White, Biolase Technology, Inc. (2001) Summary page 2.

## Cited in the summary but kept off the family tree
- K992374: Aurora HL, Premier Laser Systems, Inc. (1999). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K081214: Styla Microlaser and Stylaortho (2008), 50 descendants of its own
- K093852: Ezlase 3 Laser System (2010), 35 descendants of its own
- K121286: EPIC 10 (2012), 31 descendants of its own
- K170500: SIROLaser Advance+ (2017), 21 descendants of its own
- K062071: Prometey, Model G1-03 (2006), 17 descendants of its own

## Indications for use
The SoftLase G2 - Surgical Diode Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. Thk SofiLase G2 is intended for ablating, incising, excising, vaporization and coagulation intraoral soft tissues using a contact fiber optic delivery system. The system is also intended for use in teeth whitening procedures. The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic s u r g q , neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following are the 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 -Gingivoplasty -Incising and Draining of Abscesses -0perculectomy -Oral Papillectomy -Removal of Fibromas -Exposure of interrupted teeth -Soft Tissue Crown Lengthening -Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) -Tissue retraction for Impression -Vestibuloplasty -Light activation of bleaching materials for teeth whitening -Laser-assisted bleaching f whitening of teeth

Source page: https://510kreport.com/device/K021227
Methodology: https://510kreport.com/methodology