510(k) · Cleared
ClearedClaros Nano 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 Aug 28, 2008 as substantially equivalent to K030539 (Biolase Technology, Inc., 2003) and 1 other predicate after a 77-day review. Its family tree reaches back 3 generations to 2001. 9 later devices descend from it.
- Decided
- Aug 28, 2008
- Review
- 77 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K011041 (2001). 9 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK011041 Waterlase, MillenniumBiolase Technology, Inc. · 2001
- 2 generations backK030539 LasersmileBiolase Technology, Inc. · 2003
- 1 generation backK063152 Claros Dental Laser SystemElexxion AG · 2007
- This deviceK081652 Claros Nano Dental Laser SystemElexxion AG · 2008
- Descendant · cites it directly · 8 of its ownK091562 Doctor Smile a-810 and B-980 LasersLambda Scientific Spa · 2009
- Descendant · cites it directly · 7 of its ownK102036 Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010
- Descendant · 2 generations on · 6 of its ownK122567 Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013
- Descendant · 3 generations on · 3 of its ownK151890 Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK251077 JOULE 1064nm System and AccessoriesSciton, Inc · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa · 2009 · cites it directly8descendants
- K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010 · cites it directly7descendants
- K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013 · 2 generations on6descendants
- K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015 · 3 generations on3descendants
- K251077JOULE 1064nm System and AccessoriesSciton, Inc · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011041 | Waterlase, Millennium | Biolase Technology, Inc. | 2001 | — |
| −2 | K030539 | Lasersmile | Biolase Technology, Inc. | 2003 | — |
| −1 | K063152 | Claros Dental Laser System | Elexxion AG | 2007 | — |
| 0 (this device) | K081652 | Claros Nano Dental Laser System | Elexxion AG | 2008 | — |
| +1 | K091562 | Doctor Smile a-810 and B-980 Lasers | Lambda Scientific Spa | 2009 | — |
| +1 | K102036 | Doctor Surgery Diode Lasers Family | Lambda S.P.A. | 2010 | — |
| +2 | K122567 | Joule 810/940/980 Multi-Platform System | Sciton, Inc | 2013 | — |
| +3 | K151890 | Medical Diode Laser Systems | Wuhan Gigaa Optronics Technology Co., Ltd. | 2015 | — |
| +3 | K251077 | JOULE 1064nm System and Accessories | Sciton, Inc | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K030539 | LasersmileSummary page 1…ment Common Name: Dental Diode Laser Classification Code: · Claros nano - Class II, 21 CFR 878.4810, GEX Predicate Devices: Biolase LaserSmile, #K030539 Elexxion Claros,#K063152 Device Description: The Claros nano Dental Laser System is a variant of… | 2003 |
| * | K063152 | Claros Dental Laser SystemSummary page 1…Classification Code: · Claros nano - Class II, 21 CFR 878.4810, GEX Predicate Devices: Biolase LaserSmile, #K030539 Elexxion Claros,#K063152 Device Description: The Claros nano Dental Laser System is a variant of the Claros Dental Laser S… | 2007 |
What descends from it? (9)
2 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 7 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K091562 (Lambda Scientific Spa, 2009) has gone furthest, with 8 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. 2008, 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/K081652 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081652: Claros Nano Dental Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081652
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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