FDA 510(k)

강한 파동 조명 치료 장치 (MMABM-1)

K-번호: K251545 · 2025-09-04

신청자Micowey Medical Equipment (Guangxi) Co., Ltd.

결정일2025-09-04

제품 코드ONF

자문 위원회SU

결정Substantially Equivalent

기기 요약

Intense Pulsed Light Therapy Device (MMABM-1) is the device name listed in this FDA 510(k) record. The listed applicant is Micowey Medical Equipment (Guangxi) Co., Ltd.. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K251545. 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 Intense Pulsed Light Therapy Device (MMABM-1)?

Intense Pulsed Light Therapy Device (MMABM-1) is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Micowey Medical Equipment (Guangxi) Co., Ltd.. The 510(k) number is K251545.

When did Intense Pulsed Light Therapy Device (MMABM-1) receive FDA 510(k) clearance?

Intense Pulsed Light Therapy Device (MMABM-1) received FDA 510(k) clearance on 2025-09-04, under 510(k) number K251545.

Who is the listed applicant for Intense Pulsed Light Therapy Device (MMABM-1)?

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

What is the FDA product code for Intense Pulsed Light Therapy Device (MMABM-1)?

The FDA product code for Intense Pulsed Light Therapy Device (MMABM-1) is ONF.

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강한 파동 조명 치료 장치 (MMABM-1)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: ONF)

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