510(k) · Cleared
ClearedWaterlase MD
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 Feb 11, 2009 as substantially equivalent to K031140 (Biolase Technology, Inc., 2004) and 1 other predicate after a 16-day review. Its family tree reaches back 4 generations to 2001. 26 later devices descend from it.
- Decided
- Feb 11, 2009
- Review
- 16 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K003422 (2001). 5 ancestors in all. 26 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK003422 Edta Root Canal CleanserSuper Glide, Inc. · 2001
- 3 generations backK032361 Endopure Root Canal CleanserDentsply Intl. · 2004
- 2 generations backK053167 Biopure Mtad Root Canal CleanserDentsply Intl., Inc. · 2005
- 1 generation backK071363 Waterlase and Waterlase MDBiolase Technology, Inc. · 2008
- This deviceK090181 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
- Descendant · 3 generations on · 8 of its ownK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- 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
- K193661LightWalker Laser System FamilyFotona D.O.O. · 2020 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003422 | Edta Root Canal Cleanser | Super Glide, Inc. | 2001 | — |
| −3 | K032361 | Endopure Root Canal Cleanser | Dentsply Intl. | 2004 | — |
| −2 | K053167 | Biopure Mtad Root Canal Cleanser | Dentsply Intl., Inc. | 2005 | — |
| −1 | K071363 | Waterlase and Waterlase MD | Biolase Technology, Inc. | 2008 | — |
| 0 (this device) | 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 | — |
| +3 | K193661 | LightWalker Laser System Family | Fotona D.O.O. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K031140 | WaterlaseSummary page 1…9 GEX, a Class II device Equivalent Devices: Waterlase® MD Biolase Technology, Inc. K031140, July 7, 2004 Device Description: The Waterlase®MD is a dental laser device previously cleared by the FDA for har… | 2004 |
| * | K071363 | Waterlase and Waterlase MDSummary page 1…4 Device Description: The Waterlase®MD is a dental laser device previously cleared by the FDA for hard and soft tissue dental indications (K031140, K071363). The only changes from the previously cleared device are the addition of the Turbo handpiece, which combines minor softwar… | 2008 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101658 | Waterlase MD Turbo Plus Model 7200XXX | 2010 | 25 |
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 8 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K101658 (Biolase Technology, Inc., 2010) has gone furthest, with 25 descendants of its own.
- 3 other devices also cite its predicate K031140.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Root canal preparation including enlargement Root canal debridement and cleaning Root Canal Disinfection Laser root canal…
Read the full statement (519 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
Root canal preparation including enlargement
Root canal debridement and cleaning
Root Canal Disinfection
Laser root canal disinfection after endodontic treatment
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/K090181 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090181: Waterlase MD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090181
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