FDA 510(k)

Picosecond Laser System (Model PS10-A and PS10-B)

Número K: K220268 · 2022-08-23

RequerenteBeijing Adss Development Co., Ltd.

Data da decisão2022-08-23

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Picosecond Laser System (Model PS10-A and PS10-B) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Adss Development Co., Ltd.. It received FDA 510(k) clearance on 2022-08-23 under 510(k) number K220268. 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 Picosecond Laser System (Model PS10-A and PS10-B)?

Picosecond Laser System (Model PS10-A and PS10-B) is a medical device that received FDA 510(k) clearance on 2022-08-23. The listed applicant is Beijing Adss Development Co., Ltd.. The 510(k) number is K220268.

When did Picosecond Laser System (Model PS10-A and PS10-B) receive FDA 510(k) clearance?

Picosecond Laser System (Model PS10-A and PS10-B) received FDA 510(k) clearance on 2022-08-23, under 510(k) number K220268.

Who is the listed applicant for Picosecond Laser System (Model PS10-A and PS10-B)?

The FDA 510(k) record lists Beijing Adss Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Picosecond Laser System (Model PS10-A and PS10-B)?

The FDA product code for Picosecond Laser System (Model PS10-A and PS10-B) is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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