Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
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, 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 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 patients) - 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 eva
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) include 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. Root Canal Hard Tissue Indications include tooth preparation to obtain access to root canal, root canal preparation including enlargement, root canal debridement and cleaning. Root Canal Disinfection includes laser root canal disinfection after endodontic treatment. Endodontic Surgery (Root Amputation) Indications include flap preparation, cutting bone to prepare a window access to the apex, apicoectomy, root end preparation for retrofill amalgam or composite, and removal of pathological tissues. Bone Surgical Indications include cutting, shaving, contouring and resection of oral osseous tissues and osteotomy. Soft Tissue Indications include incision, excision, vaporization, ablation and coagulation of oral soft tissues including excisional and incisional biopsies, exposure of unerupted teeth, fibroma removal, flap preparation, frenectomy and frenotomy, gingival procedures, hemostasis, implant recovery, incision and drainage of abscesses, laser soft tissue curettage, treatment of canker sores, and vestibuloplasty.
Waterlase iPlus utilizes an Er, Cr YSGG (2780nm) solid-state laser and water atomization technology for hard and soft tissue incision, excision, ablation, vaporization and coagulation of soft and hard tissue. The laser consists of a console that houses the laser head, power supply, cooling system, micro-processor and electronics, a footswitch which activates the laser, and a fiber optic cable for delivery of laser energy through a handpiece to the treatment site. A fine water spray is also emitted from the handpiece to cool and hydrate the tissue. The laser is controlled through a touch screen display which serves as the User Interface.
Summary parsed at:2026-06-01 05:38:04 UTC
