510(k) Report

510(k) · Cleared

Cleared

Versawave Dental ER:Yag Laser System

K041710510(k) TraditionalCleared Aug 3, 200441-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Descendants, by year cleared 2008: 11 descendants cleared2010: 12 descendants cleared2004: 1 descendant cleared2006: 2 descendants cleared2012: 9 descendants cleared2017: 18 descendants cleared2009: 5 descendants cleared2011: 7 descendants cleared2018: 17 descendants cleared2015: 16 descendants cleared2007: 3 descendants cleared2013: 11 descendants cleared2022: 35 descendants cleared2020: 19 descendants cleared2021: 19 descendants cleared2014: 13 descendants cleared2016: 21 descendants cleared2019: 14 descendants cleared2026: 25 descendants cleared2023: 19 descendants cleared2025: 41 descendants cleared2024: 35 descendants cleared200020052010201520202025
  1. This deviceK041710 Versawave Dental ER:Yag Laser SystemHoya Conbio · 2004
  2. Descendant · cites it directly · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
  3. Descendant · 2 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
  4. Descendant · 3 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
  5. Descendant · cites it directly · 194 of its ownK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
  6. 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

2004: 12006: 22007: 32008: 112009: 52010: 122011: 72012: 92013: 112014: 132015: 162016: 212017: 182018: 172019: 142020: 192021: 192022: 352023: 192024: 352025: 412026: 25
2004high 41 (2025) · low 0 (2005)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K041710Versawave Dental ER:Yag Laser SystemHoya Conbio2004—
+1K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004—
+2K060033Profile Multi-Platform SystemSciton, Inc2006—
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008—
+1K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200620
200730
2008110
200950
2010120
201170
201290
2013110
2014130
2015160
2016210
2017180
2018170
2019140
2020190
2021190
2022350
2023190
2024350
2025410
2026250
FIG. 1 — Lineage of K041710, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—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 353

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226
K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194
K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083
K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063
K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122
K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080

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 devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

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.

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

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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