510(k) · Cleared
ClearedWaterlase, Version 3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolase Technology, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 13, 2008 as substantially equivalent to K030523 (Biolase Technology, Inc., 2004) after an 8-day review. Its family tree reaches back 5 generations to 1992. 1 later device descends from it.
- Decided
- Jun 13, 2008
- Review
- 8 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K922901 (1992). 19 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 4 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 3 generations backK991994 TwilightBiolase Technology, Inc. · 1999
- 2 generations backK012511 Waterlase MillenniumBiolase Technology, Inc. · 2002
- 1 generation backK030523 WaterlaseBiolase Technology, Inc. · 2004
- This deviceK081589 Waterlase, Version 3.0Biolase Technology, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK091922 Waterlase C100, Model 7100104Biolase Technology, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K091922Waterlase C100, Model 7100104Biolase Technology, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −4 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −3 | K991994 | Twilight | Biolase Technology, Inc. | 1999 | — |
| −2 | K012511 | Waterlase Millennium | Biolase Technology, Inc. | 2002 | — |
| −1 | K030523 | Waterlase | Biolase Technology, Inc. | 2004 | — |
| 0 (this device) | K081589 | Waterlase, Version 3.0 | Biolase Technology, Inc. | 2008 | — |
| +1 | K091922 | Waterlase C100, Model 7100104 | Biolase Technology, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K030523 | WaterlaseSummary page 1…I a Class II device PredicateDevices: Waterlase® Biolase Technology, Inc K030523 (January 30, 2004) DEVICE DESCRIPTION: The Waterlase®3.0hydrokinetic dental laser system is a diverse device utilized to perfo… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091922 | Waterlase C100, Model 7100104 | 2009 | 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K091922 (Biolase Technology, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K030523.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
General Indications* • 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 * For use on adult and pediatric patients Root Canal Hard Tissue Indications * Tooth preparation to obtain access to root canal M Root canal preparation including enlargement * Root canal debridement and cleaning Endodontic Surgery (Root Amputation)…
Read the full statement (514 words)
General Indications*
• 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
* For use on adult and pediatric patients
Root Canal Hard Tissue Indications
* Tooth preparation to obtain access to root canal
M 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 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*
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
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 (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.
• Soft tissue crown lengthening
• Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
• Vestibuloplasty
* For use on adult and pediatric patient
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 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081589 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081589: Waterlase, Version 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081589
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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