# K210183: Waterlase iPLus

- Pathway: 510(k) (Traditional)
- Applicant: Biolase, Inc.
- Decided: Apr 21, 2022 after 451 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: 20 generations back to K943450 (1995). 527 ancestors in all.
No later device cites it as a predicate yet.
0 of 528 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080530: Modification to Cutera ER:Ysgg Laser Handpiece, Cutera, Inc. (2008) Summary page 9.
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece, Fotona D.D. (2014) Summary page 6.

## Indications for use
Waterlase iPlus with the fractional handpiece is indicated for use in dermatology for skin resurfacing. Waterlase iPlus when used with the non-fractional handpieces is indicated for use in the following oral hard and soft tissue dental applications: Waterlase laser removal of porcelain and ceramic crowns and veneers General Hard Tissue Indications (for use on adult and pediatric patients) Class I, I, III, IV and V cavity preparation Caries removal Hard tissue surface roughening or etching Enameloplasty, excavation of pits and fissures for placement of sealants Root Canal Hard Tissue Indications Tooth preparation to obtain access to root canal Root canal preparation including enlargement Root canal debridement and cleaning Root Canal Disinfection Laser root canal disinfection after endodontic treatment 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 (for use on adult and pediatric patient) 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 Pulpotomy Pulp extirpation Pulpotomy as an adjunct to root canal therapy 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 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. 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 Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage Waterlase Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.

Source page: https://510kreport.com/device/K210183
Methodology: https://510kreport.com/methodology