FDA 510(k)

피코초 Nd:YAG 레이저 시스템 (모델: HS-298)

K-번호: K260017 · 2026-04-09

신청자Shanghai Apolo Medical Technology Co., Ltd.

결정일2026-04-09

제품 코드GEX

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

결정대체적으로 동일

기기 요약

Picosecond Nd:YAG Laser Systems (Model: HS-298) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-09 under 510(k) number K260017. 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 Systems (Model: HS-298)?

Picosecond Nd:YAG Laser Systems (Model: HS-298) is a medical device that received FDA 510(k) clearance on 2026-04-09. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K260017.

When did Picosecond Nd:YAG Laser Systems (Model: HS-298) receive FDA 510(k) clearance?

Picosecond Nd:YAG Laser Systems (Model: HS-298) received FDA 510(k) clearance on 2026-04-09, under 510(k) number K260017.

Who is the listed applicant for Picosecond Nd:YAG Laser Systems (Model: HS-298)?

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

What is the FDA product code for Picosecond Nd:YAG Laser Systems (Model: HS-298)?

The FDA product code for Picosecond Nd:YAG Laser Systems (Model: HS-298) is GEX. This falls under the Gastroenterology category.

Shanghai Apolo Medical Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K260256Q-Switched Nd: YAG 레이저 시스템 K251031파이버 레이저 치료 시스템 (HS-232, HS-233)K232409전자기 자극 시스템 K221770섬유 레이저 치료 시스템 K203395플랫폼 치료 시스템 K201731다이오드 레이저 본드 셀렉터 시스템

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