# K030523: Waterlase

- Pathway: 510(k) (Traditional)
- Applicant: Biolase Technology, Inc.
- Decided: Jan 30, 2004 after 345 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: 4 generations back to K922901 (1992). 18 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 27 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)
- K012511: Waterlase Millennium, Biolase Technology, Inc. (2002) Summary page 4.
- K013908: Waterlase Millennium, Biolase Technology, Inc. (2002) Summary page 4.
- K022803: Waterlase for Apicoectomy, Biolase Technology, Inc. (2003) Summary page 4.

## Most influential descendants
- K052354: Oculase MD (2006), 5 descendants of its own
- K063867: Cutera ER:Ysgg Laser Handpiece (2007), 2 descendants of its own
- K080530: Modification to Cutera ER:Ysgg Laser Handpiece (2008), 1 descendant of its own
- K081589: Waterlase, Version 3.0 (2008), 1 descendant of its own
- K210183: Waterlase iPLus (2022), 0 descendants of its own

## Indications for use
Use of Waterlase may be indicated for: General Indications* · Class 1,11, 111, 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 Root canal preparation including enlargement Root canal debridement and cleaning Endodontic Surgery (Root Amputation) Indications (soft and hard tissue) 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 • Incision and drainage of periapical abscesses NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathologicalevaluation. Bone Surgical Indications Cutting, shaving, contouring and resection of oral osseous tissues (bone) Osteotomy 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 and 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, gingiq/al 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 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 pena i al area during apical surgery Leukoplakia Operculectomy Oral papillectomies Pulpotomy · Pulp extirpation Pulpotomy as an adjunct to root canal therapy Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex Root canal debridement and cleaning Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa Vestibuloplasty *For use on adult and pediatric patients

Source page: https://510kreport.com/device/K030523
Methodology: https://510kreport.com/methodology