FDA 510(k)

피코초 Nd:YAG 레이저 시스템; PICO LEGEND

K-번호: K233007 · 2024-06-12

결정일2024-06-12

제품 코드GEX

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Picosecond Nd:YAG Laser System; PICO LEGEND is the device name listed in this FDA 510(k) record. The listed applicant is Ami, Inc.. It received FDA 510(k) clearance on 2024-06-12 under 510(k) number K233007. 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.

자주 묻는 질문

What is the Picosecond Nd:YAG Laser System; PICO LEGEND?

Picosecond Nd:YAG Laser System; PICO LEGEND is a medical device that received FDA 510(k) clearance on 2024-06-12. The listed applicant is Ami, Inc.. The 510(k) number is K233007.

When did Picosecond Nd:YAG Laser System; PICO LEGEND receive FDA 510(k) clearance?

Picosecond Nd:YAG Laser System; PICO LEGEND received FDA 510(k) clearance on 2024-06-12, under 510(k) number K233007.

Who is the listed applicant for Picosecond Nd:YAG Laser System; PICO LEGEND?

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

What is the FDA product code for Picosecond Nd:YAG Laser System; PICO LEGEND?

The FDA product code for Picosecond Nd:YAG Laser System; PICO LEGEND is GEX. This falls under the Gastroenterology category.

Ami, Inc.를 신청인으로 등재한 기타 기록

K173359분수 CO2 수술용 레이저 시스템 K172908Q-Switched Nd:YAG 레이저 시스템

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