FDA 510(k)

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)

K-번호: K232117 · 2023-11-28

결정일2023-11-28

제품 코드GEX

자문 위원회SU

결정Substantially Equivalent

기기 요약

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Lotuxs Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-28 under 510(k) number K232117. 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 Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)?

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is a medical device that received FDA 510(k) clearance on 2023-11-28. The listed applicant is Wuhan Lotuxs Technology Co., Ltd.. The 510(k) number is K232117.

When did Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) receive FDA 510(k) clearance?

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) received FDA 510(k) clearance on 2023-11-28, under 510(k) number K232117.

Who is the listed applicant for Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)?

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

What is the FDA product code for Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)?

The FDA product code for Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is GEX. This falls under the Gastroenterology category.

Wuhan Lotuxs Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K231910DermRays Revive K230090Diode Laser Hair Removal K191068Powersculp laser lipolysis system

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.