FDA 510(k)

Photon, Photon Plus

Número K: K162114 · 2016-12-12

RequerenteZolar Technology & Mfg Co., Inc.

Data da decisão2016-12-12

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Photon, Photon Plus is the device name listed in this FDA 510(k) record. The listed applicant is Zolar Technology & Mfg Co., Inc.. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K162114. 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 Photon, Photon Plus?

Photon, Photon Plus is a medical device that received FDA 510(k) clearance on 2016-12-12. The listed applicant is Zolar Technology & Mfg Co., Inc.. The 510(k) number is K162114.

When did Photon, Photon Plus receive FDA 510(k) clearance?

Photon, Photon Plus received FDA 510(k) clearance on 2016-12-12, under 510(k) number K162114.

Who is the listed applicant for Photon, Photon Plus?

The FDA 510(k) record lists Zolar Technology & Mfg Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Photon, Photon Plus?

The FDA product code for Photon, Photon Plus is GEX. This falls under the Gastroenterology category.

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