510(k) · Cleared
ClearedClaros Dental Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elexxion AG · GEX Powered Laser Surgical Instrument
Cleared on Mar 7, 2007 as substantially equivalent to K030539 (Biolase Technology, Inc., 2003) after a 142-day review. Its family tree reaches back 2 generations to 2001. 53 later devices descend from it.
- Decided
- Mar 7, 2007
- Review
- 142 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011041 (2001). 53 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK011041 Waterlase, MillenniumBiolase Technology, Inc. · 2001
- 1 generation backK030539 LasersmileBiolase Technology, Inc. · 2003
- This deviceK063152 Claros Dental Laser SystemElexxion AG · 2007
- Descendant · cites it directly · 51 of its ownK072262 Gentleray 980 Diode Laser SystemKavo America · 2007
- Descendant · 2 generations on · 27 of its ownK092660 Sirolaser AdvanceSirona Dental Systems GmbH · 2009
- Descendant · 3 generations on · 26 of its ownK103753 Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded…Sirona Dental Systems GmbH · 2011
- Descendant · 2 generations on · 23 of its ownK094049 Stlase Diode LaserDental Photonics, Inc. · 2010
- Descendant · 3 generations on · 22 of its ownK111689 StlaseDental Photonics, Inc. · 2012
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K072262Gentleray 980 Diode Laser SystemKavo America · 2007 · cites it directly51descendants
- K092660Sirolaser AdvanceSirona Dental Systems GmbH · 2009 · 2 generations on27descendants
- K103753Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, FonalaserSirona Dental Systems GmbH · 2011 · 3 generations on26descendants
- K094049Stlase Diode LaserDental Photonics, Inc. · 2010 · 2 generations on23descendants
- K111689StlaseDental Photonics, Inc. · 2012 · 3 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011041 | Waterlase, Millennium | Biolase Technology, Inc. | 2001 | — |
| −1 | K030539 | Lasersmile | Biolase Technology, Inc. | 2003 | — |
| 0 (this device) | K063152 | Claros Dental Laser System | Elexxion AG | 2007 | — |
| +1 | K072262 | Gentleray 980 Diode Laser System | Kavo America | 2007 | — |
| +2 | K092660 | Sirolaser Advance | Sirona Dental Systems GmbH | 2009 | — |
| +3 | K103753 | Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser | Sirona Dental Systems GmbH | 2011 | — |
| +2 | K094049 | Stlase Diode Laser | Dental Photonics, Inc. | 2010 | — |
| +3 | K111689 | Stlase | Dental Photonics, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 9 | 0 |
| 2026 | 6 | 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? (1)
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 |
|---|---|---|---|
| * | K030539 | LasersmileSummary page 1…Common Name: Dental Diode Laser Classification Code: · Clamos - Class II,21 CFR 878.4810, GEX Predicate Devices: Biolase LaserSmile, #K(030539 Device Description: The Claros Dental Laser System is a portable laser that uses a gallium… | 2003 |
What descends from it? (53)
See all 532 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 6 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K072262 (Kavo America, 2007) has gone furthest, with 51 descendants of its own.
- 6 other devices also cite its predicate K030539.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Dental 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, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscesses, Leukoplakia…
Read the full statement (176 words)
Dental 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,
Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectomy,
Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant
recovery, Incision and drainage of abscesses, Leukoplakia, Operculectomy, Oral
papillectomies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of
gingival hypertrophy, Soft tissue crown lengthening,
Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa, and
Vestibuloplasty.
*For use on adult and pediatric patients
Laser Periodontal Procedures
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, Sulcular debridement
(removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical
indices including gingival index, gingival bleeding index, probe depth, attachment loss and
tooth mobility)
Tooth Whitening
Laser assisted whitening/bleaching of teeth, Light activation for bleaching materials for teeth
whitening
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063152: Claros Dental Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063152
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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