510(k) · Cleared
ClearedWaterlase
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 Jan 30, 2004 as substantially equivalent to K011041 (Biolase Technology, Inc., 2001) and 3 other predicates after a 345-day review. Its family tree reaches back 4 generations to 1992. 8 later devices descend from it.
- Decided
- Jan 30, 2004
- Review
- 345 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K922901 (1992). 18 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 3 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 2 generations backK991994 TwilightBiolase Technology, Inc. · 1999
- 1 generation backK012511 Waterlase MillenniumBiolase Technology, Inc. · 2002
- This deviceK030523 WaterlaseBiolase Technology, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK052354 Oculase MDBiolase Technology, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK063867 Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2007
- Descendant · 3 generations on · 1 of its ownK080530 Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK081589 Waterlase, Version 3.0Biolase Technology, Inc. · 2008
- Descendant · 4 generations on · 0 of its ownK210183 Waterlase iPLusBiolase, Inc. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K052354Oculase MDBiolase Technology, Inc. · 2006 · cites it directly5descendants
- K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2007 · 2 generations on2descendants
- K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2008 · 3 generations on1descendant
- K081589Waterlase, Version 3.0Biolase Technology, Inc. · 2008 · cites it directly1descendant
- K210183Waterlase iPLusBiolase, Inc. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −3 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −2 | K991994 | Twilight | Biolase Technology, Inc. | 1999 | — |
| −1 | K012511 | Waterlase Millennium | Biolase Technology, Inc. | 2002 | — |
| 0 (this device) | K030523 | Waterlase | Biolase Technology, Inc. | 2004 | — |
| +1 | K052354 | Oculase MD | Biolase Technology, Inc. | 2006 | — |
| +2 | K063867 | Cutera ER:Ysgg Laser Handpiece | Cutera, Inc. | 2007 | — |
| +3 | K080530 | Modification to Cutera ER:Ysgg Laser Handpiece | Cutera, Inc. | 2008 | — |
| +1 | K081589 | Waterlase, Version 3.0 | Biolase Technology, Inc. | 2008 | — |
| +4 | K210183 | Waterlase iPLus | Biolase, Inc. | 2022 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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? (4)
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 |
|---|---|---|---|
| * | K011041 | Waterlase, Millennium | 2001 |
| * | K012511 | Waterlase MillenniumSummary page 4…etain the same meaning as their equivalent indications cleared by the FDA in KO1 1041 (Waterlase, expanded soft tissue indications including Sulcular Debridement), K012511 (Waterlase indications for Root Canal), K013908 (Waterlase, indications for oral osseous procedures) and K022803 (Waterlase… | 2002 |
| * | K013908 | Waterlase MillenniumSummary page 4…ations cleared by the FDA in KO1 1041 (Waterlase, expanded soft tissue indications including Sulcular Debridement), K012511 (Waterlase indications for Root Canal), K013908 (Waterlase, indications for oral osseous procedures) and K022803 (Waterlase®,indications for Endodontic Surgery). Conclusion:… | 2002 |
| * | K022803 | Waterlase for ApicoectomySummary page 4…issue indications including Sulcular Debridement), K012511 (Waterlase indications for Root Canal), K013908 (Waterlase, indications for oral osseous procedures) and K022803 (Waterlase®,indications for Endodontic Surgery). Conclusion: The indications included herein are the same as those included… | 2003 |
What descends from it? (8)
3 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)
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 12 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K052354 (Biolase Technology, Inc., 2006) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K011041.
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: General Indications* · Class 1,11, 111, 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 Endodontic…
Read the full statement (473 words)
Use of Waterlase may be indicated for:
General Indications*
· Class 1,11, 111, 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
Endodontic Surgery (Root Amputation) Indications (soft and hard tissue)
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
• Incision and drainage of periapical abscesses
NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to
a qualified laboratory for 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, gingiq/al 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
· 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 pena i al
area during apical surgery
Leukoplakia
Operculectomy
Oral papillectomies
Pulpotomy
· Pulp extirpation
Pulpotomy as an adjunct to root canal therapy
Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic
tissues (i.e., granulation tissue) from around the apex
Root canal debridement and cleaning
Reduction of gingival hypertrophy
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/K030523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030523: Waterlase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030523
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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