FDA 510(k)

아이플 헤어 레이머, 모델: G993, G996, G998 및 G885

K-번호: K211368 · 2021-10-04

결정일2021-10-04

제품 코드ONF

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

결정대체적으로 동일

기기 요약

IPL Hair Remover, Model: G993, G996, G998 and G885 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mywin Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-10-04 under 510(k) number K211368. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the IPL Hair Remover, Model: G993, G996, G998 and G885?

IPL Hair Remover, Model: G993, G996, G998 and G885 is a medical device that received FDA 510(k) clearance on 2021-10-04. The listed applicant is Shenzhen Mywin Technology Co., Ltd.. The 510(k) number is K211368.

When did IPL Hair Remover, Model: G993, G996, G998 and G885 receive FDA 510(k) clearance?

IPL Hair Remover, Model: G993, G996, G998 and G885 received FDA 510(k) clearance on 2021-10-04, under 510(k) number K211368.

Who is the listed applicant for IPL Hair Remover, Model: G993, G996, G998 and G885?

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

What is the FDA product code for IPL Hair Remover, Model: G993, G996, G998 and G885?

The FDA product code for IPL Hair Remover, Model: G993, G996, G998 and G885 is ONF.

Shenzhen Mywin Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K221679아이플 헤어 레이머, 모델: G993, G996, G998 및 G885

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