510(k) · Cleared
ClearedWaterlase Laser System Family
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 Oct 10, 2019 as substantially equivalent to K161669 (Biolase, Inc., 2016) and 1 other predicate after a 239-day review. Its family tree reaches back 12 generations to 1992. 19 later devices descend from it.
- Decided
- Oct 10, 2019
- Review
- 239 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K910422 (1992). 128 ancestors in all, the oldest K820106 (1982). 19 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations between
- 3 generations backK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- 2 generations backK101658 Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · Recalled
- 1 generation backK161669 Waterlase ExpressBiolase, Inc. · 2016
- This deviceK190319 Waterlase Laser System FamilyBiolase, Inc. · 2019
- Descendant · cites it directly · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · cites it directly · 8 of its ownK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
- Descendant · 2 generations on · 7 of its ownK202985 LightWalker Laser System FamilyFotona D.O.O. · 2021
- Descendant · 2 generations on · 3 of its ownK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
- Descendant · 2 generations on · 2 of its ownK240179 Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 10 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 9 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 8 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 7 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 6 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 5 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 4 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- 3 generations backK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- 2 generations backK101658 Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · Recalled
- 1 generation backK161669 Waterlase ExpressBiolase, Inc. · 2016
- This deviceK190319 Waterlase Laser System FamilyBiolase, Inc. · 2019
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K193656SkyPulseFotona D.O.O. · 2020 · cites it directly11descendants
- K193661LightWalker Laser System FamilyFotona D.O.O. · 2020 · cites it directly8descendants
- K202985LightWalker Laser System FamilyFotona D.O.O. · 2021 · 2 generations on7descendants
- K202991Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021 · 2 generations on3descendants
- K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd. · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −11 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −9 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −8 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −7 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −6 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −5 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −4 | K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag… | Fotona D.D. | 2005 | — |
| −3 | K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family | Fotona D.D. | 2008 | — |
| −2 | K101658 | Waterlase MD Turbo Plus Model 7200XXX | Biolase Technology, Inc. | 2010 | 1 |
| −1 | K161669 | Waterlase Express | Biolase, Inc. | 2016 | — |
| 0 (this device) | K190319 | Waterlase Laser System Family | Biolase, Inc. | 2019 | — |
| +1 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +1 | K193661 | LightWalker Laser System Family | Fotona D.O.O. | 2020 | — |
| +2 | K202985 | LightWalker Laser System Family | Fotona D.O.O. | 2021 | — |
| +2 | K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | 2021 | — |
| +2 | K240179 | Medical Diode Laser (Model: L2) | Wuhan Pioon Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 8 | 0 |
| 1999 | 5 | 0 |
| 2000 | 12 | 0 |
| 2001 | 11 | 0 |
| 2002 | 14 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K161669 | Waterlase ExpressSummary page 6…nd in dermatology (21 CFR 878.4810) Device Class: II Product Code: GEX III. PREDICATE DEVICE Waterlase Express, Biolase, Inc., K161669 Waterlase MD Turbo Plus, Biolase, Inc., K101658 IV. DEVICE DESCRIPTION Waterlase Laser System Family utilizes… | 2016 |
| * | K101658 | Waterlase MD Turbo Plus Model 7200XXXSummary page 6…: II Product Code: GEX III. PREDICATE DEVICE Waterlase Express, Biolase, Inc., K161669 Waterlase MD Turbo Plus, Biolase, Inc., K101658 IV. DEVICE DESCRIPTION Waterlase Laser System Family utilizes an Er, Cr:YSGG (2780nm) solid-state laser and wa… | 2010 |
What descends from it? (19)
See all 192 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 27 years and passes through 8 companies; a new generation was cleared every 2.3 years on median.
- 7 of the 128 ancestors have a recall of any class.
- Of its descendants, K193656 (Fotona D.O.O., 2020) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K161669.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 laser removal of porcelain and ceramic crowns and veneers General Hard Tissue Indications (for use on adult and pediatric patients) • 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 Root Canal Hard Tissue Indications • Tooth preparation to obtain access to root canal • Root canal preparation including enlargement…
Read the full statement (577 words)
Waterlase laser removal of porcelain and ceramic crowns and veneers
General Hard Tissue Indications (for use on adult and pediatric patients)
• 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
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 as stated in the FDA summary.
https://510kreport.com/device/K190319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190319: Waterlase Laser System Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190319
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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