# K081652: Claros Nano Dental Laser System

- Pathway: 510(k) (Abbreviated)
- Applicant: Elexxion AG
- Decided: Aug 28, 2008 after 77 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K011041 (2001). 3 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030539: Lasersmile, Biolase Technology, Inc. (2003) Summary page 1.
- K063152: Claros Dental Laser System, Elexxion AG (2007) Summary page 1.

## Most influential descendants
- K091562: Doctor Smile a-810 and B-980 Lasers (2009), 8 descendants of its own
- K102036: Doctor Surgery Diode Lasers Family (2010), 7 descendants of its own
- K122567: Joule 810/940/980 Multi-Platform System (2013), 6 descendants of its own
- K151890: Medical Diode Laser Systems (2015), 3 descendants of its own
- K251077: JOULE 1064nm System and Accessories (2025), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K081652
Methodology: https://510kreport.com/methodology