FDA 510(k)

로즈 III 멀티 파동 Er: Yag 레이저 시스템

K-번호: K182045 · 2018-12-27

결정일2018-12-27

제품 코드GEX

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

결정대체적으로 동일

기기 요약

Lotus III Multi-Pulsed Er: Yag Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Laseroptek Co., Ltd.. It received FDA 510(k) clearance on 2018-12-27 under 510(k) number K182045. 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 Lotus III Multi-Pulsed Er: Yag Laser System?

Lotus III Multi-Pulsed Er: Yag Laser System is a medical device that received FDA 510(k) clearance on 2018-12-27. The listed applicant is Laseroptek Co., Ltd.. The 510(k) number is K182045.

When did Lotus III Multi-Pulsed Er: Yag Laser System receive FDA 510(k) clearance?

Lotus III Multi-Pulsed Er: Yag Laser System received FDA 510(k) clearance on 2018-12-27, under 510(k) number K182045.

Who is the listed applicant for Lotus III Multi-Pulsed Er: Yag Laser System?

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

What is the FDA product code for Lotus III Multi-Pulsed Er: Yag Laser System?

The FDA product code for Lotus III Multi-Pulsed Er: Yag Laser System is GEX. This falls under the Gastroenterology category.

Laseroptek Co., Ltd.를 신청인으로 등재한 기타 기록

K243780HELIOS 785 Pico (1754V2)K230373헬리오스 785 피코 K223588팔라스 프리미엄 K212663헬리오스 IV 785 K212573피코로 프리미엄 K203491PicoLO Nd: YAG 피코초 레이저 시스템

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