FDA 510(k)

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser

Номер K: K222485 · 2023-03-29

ЗаявительIds, Limited

Дата решения2023-03-29

Код продуктаGEX

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser is the device name listed in this FDA 510(k) record. The listed applicant is Ids, Limited. It received FDA 510(k) clearance on 2023-03-29 under 510(k) number K222485. 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.

Часто задаваемые вопросы

What is the SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser?

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser is a medical device that received FDA 510(k) clearance on 2023-03-29. The listed applicant is Ids, Limited. The 510(k) number is K222485.

When did SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser receive FDA 510(k) clearance?

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser received FDA 510(k) clearance on 2023-03-29, under 510(k) number K222485.

Who is the listed applicant for SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser?

The FDA 510(k) record lists Ids, Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser?

The FDA product code for SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser is GEX. This falls under the Gastroenterology category.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: GEX)

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Официальный источник

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