# K163638: Dental 5 Multi Diode laser

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Med USA, Inc.
- Decided: May 15, 2017 after 143 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: 6 generations back to K922901 (1992). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063384: Diodent Micro Dental Laser System, Models 810 and 980, Hoya Conbio, Inc. (2007) Summary page 4.

## Indications for use
This device indicated for use the Incision, Alblation, Vaporization and Hemostasis of oral soft tissue such as, Excisional and Incisional biopsies, Exposure of Un-erupted teeth, Fibroma Removal, Frenectomy and Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingvioplasty, Gingival Incision and Excision, 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, Sulcular debridement, Treatment of aphthous ulcers Vestibuloplasty, Biopsy incision and excision, lesion (tumor) removal, Light activation for bleaching material, for laser assisted bleaching/ whitening for teeth.

Source page: https://510kreport.com/device/K163638
Methodology: https://510kreport.com/methodology