# K093048: D-Storm 810NM, D-Storm 980NM

- Pathway: 510(k) (Traditional)
- Applicant: Light Instruments
- Decided: Mar 23, 2010 after 174 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: 9 generations back to K931783 (1993). 68 ancestors in all.
No later device cites it as a predicate yet.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073411: Liteduo, Light Instruments (2008) Summary page 2.
- K063384: Diodent Micro Dental Laser System, Models 810 and 980, Hoya Conbio, Inc. (2007) Summary page 2.
- K083034: Fotona XD-2 Diode Laser System, Model MD01-2F, Fotona D.D. (2009) Summary page 2.

## Indications for use
The D-Storm system is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry. The D-Storm diode laser system is indicated for: * Incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry • Light activation of bleaching materials for teeth whitening The D-Storm specific indications include the following: Marginal and interdental gingiva and epithelia] lining of free gingiva, frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gignigivioplasty, gingival troughing crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelia] lining, incision and draining of abscesses, tissue retraction, for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphtous ulcers, leukoplakia, sulcular debridemnent (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy as adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Source page: https://510kreport.com/device/K093048
Methodology: https://510kreport.com/methodology