510(k) · Cleared
ClearedWaterlase iPLus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolase, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Apr 21, 2022 as substantially equivalent to K080530 (Cutera, Inc., 2008) and 1 other predicate after a 451-day review. Its family tree reaches back 20 generations to 1995.
- Decided
- Apr 21, 2022
- Review
- 451 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K943450 (1995). 527 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 2 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 1 generation backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- This deviceK210183 Waterlase iPLusBiolase, Inc. · 2022
Show all 20 generations
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 15 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 14 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 13 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 12 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 9 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 8 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 7 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 6 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 5 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 4 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 3 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 2 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 1 generation backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- This deviceK210183 Waterlase iPLusBiolase, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −19 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −15 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −14 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −13 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −12 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −9 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −8 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −7 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −6 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −5 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −4 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −3 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −1 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| 0 (this device) | K210183 | Waterlase iPLus | Biolase, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 4 | 0 |
| 1990 | 7 | 0 |
| 1991 | 9 | 0 |
| 1992 | 5 | 0 |
| 1993 | 12 | 0 |
| 1994 | 25 | 0 |
| 1995 | 26 | 0 |
| 1996 | 30 | 0 |
| 1997 | 34 | 0 |
| 1998 | 30 | 0 |
| 1999 | 25 | 0 |
| 2000 | 34 | 0 |
| 2001 | 32 | 0 |
| 2002 | 44 | 0 |
| 2003 | 49 | 0 |
| 2004 | 36 | 0 |
| 2005 | 28 | 0 |
| 2006 | 16 | 0 |
| 2007 | 17 | 0 |
| 2008 | 20 | 0 |
| 2009 | 7 | 0 |
| 2010 | 3 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K080530 | Modification to Cutera ER:Ysgg Laser HandpieceSummary page 9…Fractional Biolase iPlus S Handpiece Handpiece Handpiece 510(k) Number K210183 K080530 K132806 K141975 Laser medium Er,Cr YSGG Er YSGG Er YAG Er,Cr YSGG Wavelength… | 2008 |
| * | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceSummary page 6…e Class: II Product Code: GEX, ONG ,,, PREDICATE DEVICE6 3HDUO)UDFWLRQDO+DQGSLHFH&XWHUD,QF. FS-01 Handpiece, FotonaGG K132806 R()(5(1&('(9,&( Waterlase iPlus S, Biolase, Inc., K141975 ,9 DEVICE DESCRIPTION Waterlase iPlus utilizes an Er,… | 2014 |
| † | K141975 | Waterlase Iplus S | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 9 companies; a new generation was cleared every 11 months on median.
- 26 of the 527 ancestors have a recall of any class.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Waterlase iPlus with the fractional handpiece is indicated for use in dermatology for skin resurfacing. Waterlase iPlus when used with the non-fractional handpieces is indicated for use in the following oral hard and soft tissue dental applications: Waterlase laser removal of porcelain and ceramic crowns and veneers General Hard Tissue Indications (for use on adult and pediatric patients) Class I, I, III, IV and V cavity preparation Caries removal Hard…
Read the full statement (560 words)
Waterlase iPlus with the fractional handpiece is indicated for use in dermatology for skin resurfacing.
Waterlase iPlus when used with the non-fractional handpieces is indicated for use in the following oral hard and soft tissue dental applications:
Waterlase laser removal of porcelain and ceramic crowns and veneers
General Hard Tissue Indications (for use on adult and pediatric patients)
Class I, I, III, IV and V cavity preparation
Caries removal
Hard tissue surface roughening or etching
Enameloplasty, excavation of pits and fissures for placement of sealants
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 (for use on adult and pediatric patient)
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
Pulpotomy
Pulp extirpation
Pulpotomy as an adjunct to root canal therapy
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
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.
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
Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage
Waterlase Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210183: Waterlase iPLus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210183
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