Dental Diode Laser Device (Laser-Pen)— 510(k) K261047

Name: FDA 510(k) clearance K261047
Creator: U.S. Food and Drug Administration
Published: 2026-09-18

Substantially Equivalent

Guilin Kevin Peter Technology Co., Ltd.

FDA 510(k) clearance K261047 for Dental Diode Laser Device (Laser-Pen), Substantially Equivalent on 2026-09-18. Applicant: Guilin Kevin Peter Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guilin Kevin Peter Technology Co., Ltd.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2026-03-31
Decision date: 2026-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guilin, CN

Download summary PDF View on FDA.gov ↗

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K252723 — Dynamis Pro Family2026-09-19
K261673 — LED Therapy Device (QLXY-01)2026-09-17
K261817 — Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)2026-09-17
K262877 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)2026-09-16

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.