FDA 510(k)

Dental Diode Laser Device (Laser-Pen)

Número K: K261047 · 2026-09-18

RequerenteGuilin Kevin Peter Technology Co., Ltd.

Data da decisão2026-09-18

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental Diode Laser Device (Laser-Pen) is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Kevin Peter Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-09-18 under 510(k) number K261047. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dental Diode Laser Device (Laser-Pen)?

Dental Diode Laser Device (Laser-Pen) is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is Guilin Kevin Peter Technology Co., Ltd.. The 510(k) number is K261047.

When did Dental Diode Laser Device (Laser-Pen) receive FDA 510(k) clearance?

Dental Diode Laser Device (Laser-Pen) received FDA 510(k) clearance on 2026-09-18, under 510(k) number K261047.

Who is the listed applicant for Dental Diode Laser Device (Laser-Pen)?

The FDA 510(k) record lists Guilin Kevin Peter Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Diode Laser Device (Laser-Pen)?

The FDA product code for Dental Diode Laser Device (Laser-Pen) is GEX. This falls under the Gastroenterology category.

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