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FDA 510(k)

O-pel Laser and families of probe delivery devices

Número K: K160012 · 2016-06-02

RequerentePrecise Light Surgical
Data da decisão2016-06-02
Código do produtoGEX
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

O-pel Laser and families of probe delivery devices is the device name listed in this FDA 510(k) record. The listed applicant is Precise Light Surgical. It received FDA 510(k) clearance on 2016-06-02 under 510(k) number K160012. 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 O-pel Laser and families of probe delivery devices?

O-pel Laser and families of probe delivery devices is a medical device that received FDA 510(k) clearance on 2016-06-02. The listed applicant is Precise Light Surgical. The 510(k) number is K160012.

When did O-pel Laser and families of probe delivery devices receive FDA 510(k) clearance?

O-pel Laser and families of probe delivery devices received FDA 510(k) clearance on 2016-06-02, under 510(k) number K160012.

Who is the listed applicant for O-pel Laser and families of probe delivery devices?

The FDA 510(k) record lists Precise Light Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O-pel Laser and families of probe delivery devices?

The FDA product code for O-pel Laser and families of probe delivery devices is GEX. This falls under the Gastroenterology category.

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