510(k) · Cleared
ClearedVersawave Dental ER:Yag Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hoya Conbio · GEX Powered Laser Surgical Instrument
Cleared on Aug 3, 2004 after a 41-day review. The FDA summary names its predicate without a number. 353 later devices descend from it.
- Decided
- Aug 3, 2004
- Review
- 41 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
353 later devices descend from it, 6 citing it directly.
- This deviceK041710 Versawave Dental ER:Yag Laser SystemHoya Conbio · 2004
- Descendant · cites it directly · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- Descendant · 2 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 3 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · cites it directly · 194 of its ownK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- Descendant · 4 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
Showing 5 of 353 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 353 · See all- K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · cites it directly226descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 2 generations on221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 3 generations on202descendants
- K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008 · cites it directly194descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 4 generations on192descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041710 | Versawave Dental ER:Yag Laser System | Hoya Conbio | 2004 | — |
| +1 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| +2 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +3 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +1 | K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family | Fotona D.D. | 2008 | — |
| +4 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 11 | 0 |
| 2009 | 5 | 0 |
| 2010 | 12 | 0 |
| 2011 | 7 | 0 |
| 2012 | 9 | 0 |
| 2013 | 11 | 0 |
| 2014 | 13 | 0 |
| 2015 | 16 | 0 |
| 2016 | 21 | 0 |
| 2017 | 18 | 0 |
| 2018 | 17 | 0 |
| 2019 | 14 | 0 |
| 2020 | 19 | 0 |
| 2021 | 19 | 0 |
| 2022 | 35 | 0 |
| 2023 | 19 | 0 |
| 2024 | 35 | 0 |
| 2025 | 41 | 0 |
| 2026 | 25 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | DELig-ht Dental Er:YAG Laser System Named without a submission number | |
| * | — | WaterLase, Millennium Dental Laser System Named without a submission number | |
| * | — | Premrier Centauri Dental Laser System Named without a submission number |
What descends from it? (353)
See all 3536 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | 2004 | 226 |
| K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family | 2008 | 194 |
| K093162 | Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis… | 2010 | 83 |
| K061966 | Litetouch Dental Laser System | 2006 | 3 |
| K120377 | Adverl Evo ER: Yag Laser for Dentistry Mey-1-a | 2012 | 2 |
| K073158 | Sculpture 2.94 ER:Yag System | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040270 (Lumenis, Ltd., 2004) has gone furthest, with 226 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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…
Read the full statement (525 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041710: Versawave Dental ER:Yag Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041710
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026