FDA 510(k)

오렌 LED 주변 표면 조명 치료 시스템

K-번호: K213024 · 2021-12-22

결정일2021-12-22

제품 코드OHS

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

결정대체적으로 동일

기기 요약

Oren LED Perioral Light Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical CO , Ltd.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K213024. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Oren LED Perioral Light Therapy System?

Oren LED Perioral Light Therapy System is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Shenzhen Kaiyan Medical CO , Ltd.. The 510(k) number is K213024.

When did Oren LED Perioral Light Therapy System receive FDA 510(k) clearance?

Oren LED Perioral Light Therapy System received FDA 510(k) clearance on 2021-12-22, under 510(k) number K213024.

Who is the listed applicant for Oren LED Perioral Light Therapy System?

The FDA 510(k) record lists Shenzhen Kaiyan Medical CO , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oren LED Perioral Light Therapy System?

The FDA product code for Oren LED Perioral Light Therapy System is OHS.

Shenzhen Kaiyan Medical CO , Ltd.를 신청인으로 등재한 기타 기록

K220168스킨케어 비욘드 미스터리 마스크 (모델: MJ-06)K203214데마크쿼 웨이, 데마크쿼 팝 K203271Aduro light therapy Handheld K202390Aduro Light Beauty Mask

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