Manufacturer
Biolase, Inc.Waterlase Laser System Family
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K190319
- Device name
- Waterlase Laser System Family
- Company
- Biolase, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-02-13
- Decision date
- 2019-10-10
- Submission type
- Traditional
- Technology type
- Er:YAG(AI inferred)
- Clinical applications
- Surgical cuttingOtherDentalSkin resurfacing
- Primary application
- Dental
- Classification source
- AI classified
Indications for Use
Waterlase Laser System Family is intended for use in oral hard and soft tissue dental applications. The Indications for Use are as follows: 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 evaluation. Laser Periodontal Procedures • Full thickness flap • Partial thickness flap • Split thickness flap • Laser soft tissue curettage • Laser removal of diseased,
Intended Use
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. 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.
Device Description
Waterlase Laser System Family utilizes an Er, Cr:YSGG (2780nm) solid-state laser and water atomization technology to safely and effectively cut, shave, contour, roughen, etch and resect oral hard-tissue and direct laser energy to perform oral soft tissue removal, incision, excision, ablation and coagulation. It is also used for specific endodontic and periodontal applications. A single laser console houses the laser head, power supply, cooling system, micro-processor. The laser is controlled through a display which serves as the User Interface. A flexible fiber optic cable, connected to the laser, delivers laser energy to the treatment site through a laser tip attached to a handpiece. A visible light emitted from the handpiece head illuminates the area. A fine water spray is also emitted from the handpiece head to cool and hydrate the issue. A variety of laser tips are available for different clinical applications. The laser is activated by a footswitch.
Summary parsed at:2026-06-01 05:55:09 UTC
Predicate devices
2—
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Not ingested
Waterlase Express
K190319 references 2 predicate/reference devices
Cited as predicate
2SkyPulse
LightWalker Laser System Family
2 submissions cite K190319 as a predicate
