FDA 510(k)

LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)

K-번호: K260946 · 2026-06-18

결정일2026-06-18

제품 코드OHS

자문 위원회SU

결정Substantially Equivalent

기기 요약

LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K260946. 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 LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)?

LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. The 510(k) number is K260946.

When did LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) receive FDA 510(k) clearance?

LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K260946.

Who is the listed applicant for LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)?

The FDA 510(k) record lists Guangdong Newdermo Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)?

The FDA product code for LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) is OHS.

Guangdong Newdermo Biotech Co., Ltd.를 신청인으로 등재한 기타 기록

K261370LED 라이트 테라피 마스크 (LED 페이스 마스크 파ulse (FAC06NA))K261052LED 라이트 테라피 마스크 (LED 페이스 마스크 프로 FAC08NA, LED 청부 마스크 프로 FAC09NA)K260202LED 라이트 테라피 마스크 (LumiLips FAC07NA)K223544LED 라이트 테라피 마스크 (FM-01, FM-02, FM-03)

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