# K091562: Doctor Smile a-810 and B-980 Lasers

- Pathway: 510(k) (Abbreviated)
- Applicant: Lambda Scientific Spa
- Decided: Sep 8, 2009 after 103 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: 17 generations back to K943450 (1995). 197 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 206 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073322: Fox 1-980, Fox Q-1064, Fox-Q-810, A.R.C Laser GmbH (2008) Summary page 1.
- K082938: Ezlase, Biolase Technology, Inc. (2008) Summary page 1.
- K053161: Sirolaser, Sirona Dental Systems GmbH (2006) Summary page 1.
- K072262: Gentleray 980 Diode Laser System, Kavo America (2007) Summary page 1.
- K072779: Ceralas D 980NM Diode Laser, Models D15 and D25, Biolitec, Inc. (2008) Summary page 1.
- K081652: Claros Nano Dental Laser System, Elexxion AG (2008) Summary page 1.

## Most influential descendants
- 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
- K252063: Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) (2025), 0 descendants of its own

## Indications for use
Doctor Smile A-810 Laser is intended for use in the following procedure: Soft Tissue, Laser Periodontal procedures and tooth whitening Intra- and extra oral surgery including incision, excision, vaporization, ablation, haemostasis and coagulation of oral soft tissues, Laser soft tissue, curettage, whitening. Following specific indications: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingivoplasty, Gingival incision and excision Haemostasis and coagulation, Implant recovery, Incision and drainage of abscess 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, Vestibuloplasty. Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket. Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.). Light activation of whitening/bleaching material. Doctor Smile B-980 Laser is intended for use in the following procedure: Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissue in medical specialties including dentistry, gastroenterology, dermatology, general surgery, gynecology, opthamology, pulmonology, otolaryngology, othopedics. Dental applications: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Haemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials

Source page: https://510kreport.com/device/K091562
Methodology: https://510kreport.com/methodology