# K122368: Waterlase Iplus All Tissue Laser

- Pathway: 510(k) (Traditional)
- Applicant: Biolase Technology, Inc.
- Decided: May 2, 2013 after 269 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: 10 generations back to K910422 (1992). 236 ancestors in all.
No later device cites it as a predicate yet.
0 of 237 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060033: Profile Multi-Platform System, Sciton, Inc (2006) Summary page 1.
- K092964: Cooltouch Varia ND:Yag Laser System, New Star Lasers, Inc. (2009) Summary page 1.
- K090776: Megapulse Laser System and Fibers, Richard Wolf Medical Instruments Corp. (2009) Summary page 1.
- K021548: Fotona Dualis ND:Yag/ER:Yag Laser System, Fotona D.D. (2002) Summary page 1.

## Indications for use
The Orthopedic iPlus Soft Tissue Laser is intended for use as a laser surgical instrument in orthopedic and podiatric surgery. It is indicated for the following Indications for Use, including the previously cleared dental indications, for completeness: DENTAL INDICATIONS FOR USE 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 Tooth preparation to obtain access to root canal Root canal preparation including enlargement Root canal debridement and cleaning Laser root canal disinfection after endodontic treatment 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. Cutting, shaving, contouring and resection of oral osseous tissues (bone) Osteotomy 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 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 patients 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 bacterial perpetration 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 MD Er,Cr:YSSG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium) ORTHOPEDIC INDICATIONS FOR USE Incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an arthroscope, in contact and non-contact with tissue, in orthopedic and podiatric surgery, including: Soft and cartilaginous tissue in small and large joints (e.g., knee meniscectomy, debridement of inflamed synovial tissue)

Source page: https://510kreport.com/device/K122368
Methodology: https://510kreport.com/methodology