# K041710: Versawave Dental ER:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Hoya Conbio
- Decided: Aug 3, 2004 after 41 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
No predicates in its family tree.
353 later devices descend from it; 6 cite it directly.
0 of 354 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DELig-ht Dental Er:YAG Laser System: named in the summary without a submission number
- (no number) WaterLase, Millennium Dental Laser System: named in the summary without a submission number
- (no number) Premrier Centauri Dental Laser System: named in the summary without a submission number

## Most influential descendants
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K070355: Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family (2008), 194 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own

## Indications for use
Hard Tissue General Indications* * Class I, 1, III, IV and V cavity preparation * Carries 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 Root Canal Hard Tissue Indications * Tooth preparation to obtain access to root canal * Root canal preparation including enlargement Root canal debridement and cleaning Bone Surgical Indications * Cutting, shaving, contouring and resection of oral osseous tissues (bone) * Osteotomy 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. cysts, neoplasm, or other lesions) must be submitted to a qualified laboratoryfor histopathologicalevaluation. 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 bactena penetraton ot the pocket lining and junctional epithelium * Removal of granulation tissue from bony defects Sulcular debridement (removal of diseased, infected, inflamed gingival index. in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility) * Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiological 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 the unerupted teeth (hard and soft tissue impactions) * Frenectomy and frenotomy * Gingival troughing for crown impressions - Gingivectomy *Gingivoplasty •Gingival incision and excision *Hemostasis and coagulation * Implant recovery * Incision and drainage of abscesses •Incision and drainage of periapical 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 * Reduction of gingival hypertrophy * Removal of pathological tissues (i.e. cysts, neoplasm, abscess) and hyperplastic tissues (i.e. granulation tissue). Note: any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratoryfor histopathological evaluation. *Root canal debridement and cleaning *Soft tissue crown lengthening * Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa * Vestibuloplaty *For use on adult and pediatric patients

Source page: https://510kreport.com/device/K041710
Methodology: https://510kreport.com/methodology