# K083069: Ezlase 10W

- Pathway: 510(k) (Special)
- Applicant: Biolase Technology, Inc.
- Decided: Nov 13, 2008 after 29 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 K922901 (1992). 13 ancestors in all.
36 later devices descend from it; 3 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061898: Ezlase, Biolase Technology, Inc. (2007) Summary page 1.
- K991994: Twilight, Biolase Technology, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K180044: SIROLaser Blue (2018), 12 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own

## Indications for use
Dental Soft Tissue Indications for: Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa Vestibuloplasty Laser Periodontal procedures, including: Laser soft tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)

Source page: https://510kreport.com/device/K083069
Methodology: https://510kreport.com/methodology