510(k) Report

510(k) · Cleared

Recalled · 2005

Waterlase

K031140510(k) TraditionalCleared Jul 7, 2004454-day reviewClass II21 CFR 878.4810Recalls 1

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

Biolase Technology, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jul 7, 2004 after a 454-day review. The FDA summary names no predicate by number. 33 later devices descend from it. It has been recalled once.

Decided
Jul 7, 2004
Review
454 days
Class
Class II
Product code
GEX
Recalls
1
Predicates
0

33 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2007: 2 descendants cleared2006: 1 descendant cleared2009: 1 descendant cleared2015: 2 descendants cleared2008: 1 descendant cleared2016: 1 descendant cleared2019: 1 descendant cleared2012: 1 descendant cleared2022: 4 descendants cleared2021: 3 descendants cleared2020: 2 descendants cleared2026: 4 descendants cleared2023: 2 descendants cleared2025: 4 descendants cleared2024: 3 descendants cleared200020052010201520202025
  1. This deviceK031140 WaterlaseBiolase Technology, Inc. · 2004
  2. Descendant · cites it directly · 26 of its ownK090181 Waterlase MDBiolase Technology, Inc. · 2009
  3. Descendant · cites it directly · 25 of its ownK101658 Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · Recalled
  4. Descendant · 2 generations on · 21 of its ownK161669 Waterlase ExpressBiolase, Inc. · 2016
  5. Descendant · 2 generations on · 19 of its ownK190319 Waterlase Laser System FamilyBiolase, Inc. · 2019
  6. Descendant · 3 generations on · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22008: 12009: 12010: 12012: 12015: 22016: 12019: 12020: 22021: 32022: 42023: 22024: 32025: 42026: 4
2006high 4 (2022) · low 0 (2011)2026

Most influential descendants

Showing 5 of 33 · See all
  • K090181Waterlase MDBiolase Technology, Inc. · 2009 · cites it directly26descendants
  • K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · cites it directly25descendants
  • K161669Waterlase ExpressBiolase, Inc. · 2016 · 2 generations on21descendants
  • K190319Waterlase Laser System FamilyBiolase, Inc. · 2019 · 2 generations on19descendants
  • K193656SkyPulseFotona D.O.O. · 2020 · 3 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K031140WaterlaseBiolase Technology, Inc.2004—
+1K090181Waterlase MDBiolase Technology, Inc.2009—
+1K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.20101
+2K161669Waterlase ExpressBiolase, Inc.2016—
+2K190319Waterlase Laser System FamilyBiolase, Inc.2019—
+3K193656SkyPulseFotona D.O.O.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200810
200910
201010
201210
201520
201610
201910
202020
202130
202240
202320
202430
202540
202640
FIG. 1 — Lineage of K031140, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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?

The FDA summary names no predicate by number.

What descends from it? (33)

See all 33

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

NumberDeviceApplicantDecidedDescendants
K090181Waterlase MDBiolase Technology, Inc.200926
K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.201025
K052354Oculase MDBiolase Technology, Inc.20065
K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 17, 2005Not classifiedZ-0543-05OtherReports that the Waterlase MD, a dental laser unit, water bottle broke under pressure during installation.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K090181 (Biolase Technology, Inc., 2009) has gone furthest, with 26 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?

Use of Waterlase® may be indicated for. Hard Tissue General Indications* * Class,i,III, IVand V cavity preparation * Caries 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…

Read the full statement (491 words)

Use of Waterlase® may be indicated for.

Hard Tissue

General Indications*

* Class,i,III, IVand V cavity preparation

* Caries 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

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 orother/esions)must be submitted to a qualified laboratoryfor histopathologicalevaluation.

Bone Surgical Indications

* Cutting, shaving, contouring and resection of oral osseous tissues (bone)

- Osteotomy

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 bacteria penetration of the pocket lining and junctional epithelium

* Removal of granulation tissue from bony defects

Sulcular debridement (removal of diseased, infected, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)

* Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic 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

Fibmma 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

· Removal of pathological tissues (ie., cysts, neoplasm or abscess) and hyperplastic tissues (ie., granulation tissue) from around the apex

NOTE: Any tissue growth (le., cyst neoplasm or other lesions) must be submitted to a qualified laboratoryfor hlstopathologicalevaluation.

• Soft tissue crown lengthening

· Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa

· Vestibuloplasty

*For use on adult and pediatric patients

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K031140: Waterlase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031140

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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