# K081589: Waterlase, Version 3.0

- Pathway: 510(k) (Special)
- Applicant: Biolase Technology, Inc.
- Decided: Jun 13, 2008 after 8 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: 5 generations back to K922901 (1992). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030523: Waterlase, Biolase Technology, Inc. (2004) Summary page 1.

## Most influential descendants
- K091922: Waterlase C100, Model  7100104 (2009), 0 descendants of its own

## Indications for use
General Indications* • Class I, II, III, IV and V cavity preparation * Caries removal • Hard tissue surface roughening or etching · Enameloplasty, excavation of pits and fissures for placement of sealants * For use on adult and pediatric patients Root Canal Hard Tissue Indications * Tooth preparation to obtain access to root canal M Root canal preparation including enlargement * Root canal debridement and cleaning Endodontic Surgery (Root Amputation) Indications * Flap preparation - incision of soft tissue to prepare a flap and expose the bone. * Cutting bone to prepare a window access to the apex (apices) of the root(s). * Apicoectomy - amputation of the root end. • Root end preparation for retrofill amalgam or composite. · Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. Bone Surgical Indications * Cutting, shaving, contouring and resection of oral osseous tissues (bone) * Osteotomy Soft Tissue Indications including Pulpal Tissues* Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: · Excisional and incisional biopsies · Exposure of unerupted teeth · Fibroma removal * Flap preparation - incision of soft tissue to prepare a flap and expose the bone. * Flap preparation - incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions) · Frenectomy and frenotomy * Gingival troughing for crown impressions · Gingivectomy * Gingivoplasty · Gingival incision and excision * Hemostasis implant recovery * Incision and drainage of abscesses • Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery , Leukoplakia , Operculectomy Oral papillectomies Operculectomy · Oral papillectomies • Pulpotomy * Pulp extirpation * Pulpotomy as an adjunct to root canal therapy * Root canal debridement and cleaning • Reduction of gingival hypertrophy • Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. • Soft tissue crown lengthening • Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa • Vestibuloplasty * For use on adult and pediatric patient Laser Periodontal Procedures * Full thickness flap · Partial thickness flap Split thickness flap * 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 junctional epithelium Removal of granulation tissue from bony defects Sulcular debridement (removal of diseased, infected, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) · Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours) Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.) Osseous crown lengthening

Source page: https://510kreport.com/device/K081589
Methodology: https://510kreport.com/methodology