510(k) · Cleared
Recalled · 2005Waterlase
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 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.
- This deviceK031140 WaterlaseBiolase Technology, Inc. · 2004
- Descendant · cites it directly · 26 of its ownK090181 Waterlase MDBiolase Technology, Inc. · 2009
- Descendant · cites it directly · 25 of its ownK101658 Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 21 of its ownK161669 Waterlase ExpressBiolase, Inc. · 2016
- Descendant · 2 generations on · 19 of its ownK190319 Waterlase Laser System FamilyBiolase, Inc. · 2019
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031140 | Waterlase | Biolase Technology, Inc. | 2004 | — |
| +1 | K090181 | Waterlase MD | Biolase Technology, Inc. | 2009 | — |
| +1 | K101658 | Waterlase MD Turbo Plus Model 7200XXX | Biolase Technology, Inc. | 2010 | 1 |
| +2 | K161669 | Waterlase Express | Biolase, Inc. | 2016 | — |
| +2 | K190319 | Waterlase Laser System Family | Biolase, Inc. | 2019 | — |
| +3 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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?
The FDA summary names no predicate by number.
What descends from it? (33)
See all 334 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 17, 2005 | Not classified | Z-0543-05 | Other | Reports 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 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?
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.
https://510kreport.com/device/K031140 · printed Nov 6, 2026
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
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