# K030539: Lasersmile

- Pathway: 510(k) (Traditional)
- Applicant: Biolase Technology, Inc.
- Decided: Oct 10, 2003 after 232 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 K011041 (2001). 1 ancestor in all.
327 later devices descend from it; 7 cite it directly.
0 of 329 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011041: Waterlase, Millennium, Biolase Technology, Inc. (2001)

## Cited in the summary but kept off the family tree
- K91994: Twilite. Number could not be read Summary page 3.

## Most influential descendants
- K061898: Ezlase (2007), 289 descendants of its own
- K072034: Diode Medical Laser Family, Models 4, 6, 30 (2007), 263 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K050453: Odyssey 2.4G, Denlaser Elite, Model 002-00050 (2005), 86 descendants of its own

## Indications for use
Dental Soft Tissue Indications for: Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: 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 Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) Tooth whitening procedures, including: Light activation for bleaching materials for teeth whitening Laser-assisted whitening/bleaching of teeth.

Source page: https://510kreport.com/device/K030539
Methodology: https://510kreport.com/methodology