# K261047: Dental Diode Laser Device (Laser-Pen)

- Pathway: 510(k) (Traditional)
- Applicant: Guilin Kevin Peter Technology Co., Ltd.
- Decided: Sep 18, 2026 after 171 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: 21 generations back to K943450 (1995). 267 ancestors in all.
No later device cites it as a predicate yet.
0 of 268 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200693: K2 Mobile, Hulaser, Inc. (2020) Summary page 5.
- K192430: Epic 980, Biolase, Inc. (2019) Summary page 6.

## Indications for use
Laser-Pen is intended for use by dentists for excision, incision, vaporization, ablation and coagulation of oral soft tissue procedures, including Tooth Whitening and the temporary relief of pain. The Specific indications are as follows: Endodontic procedures: Pulpotomy, Root canal therapy Periodontal procedures: Sulcular debridement Implant procedures: Implant recovery Surgery procedures: Biopsies, Crown lengthening, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Gingivectomy, Gingivoplasty, Incision and drainage of abscess, Operculectomy,Papillectomies, Reduction of gingival hypertrophy, Vestibuloplasty Other procedures: Gingival troughing, Hemostasis and coagulation Leukoplakia, Treatment of aphthous-ulcer canker sores and herpetic, Laser Assisted whitening, Topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain and stiffness minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relation of muscle.

Source page: https://510kreport.com/device/K261047
Methodology: https://510kreport.com/methodology