FDA 510(k)

글램 LED 얼굴 마스크 (TB-2386F)

K-번호: K251727 · 2025-08-29

신청자Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.

결정일2025-08-29

제품 코드GEX

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

결정대체적으로 동일

기기 요약

GLAM LED Facial Mask (TB-2386F) is the device name listed in this FDA 510(k) record. The listed applicant is Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K251727. 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 GLAM LED Facial Mask (TB-2386F)?

GLAM LED Facial Mask (TB-2386F) is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.. The 510(k) number is K251727.

When did GLAM LED Facial Mask (TB-2386F) receive FDA 510(k) clearance?

GLAM LED Facial Mask (TB-2386F) received FDA 510(k) clearance on 2025-08-29, under 510(k) number K251727.

Who is the listed applicant for GLAM LED Facial Mask (TB-2386F)?

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

What is the FDA product code for GLAM LED Facial Mask (TB-2386F)?

The FDA product code for GLAM LED Facial Mask (TB-2386F) is GEX. This falls under the Gastroenterology category.

Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.를 신청인으로 등재한 기타 기록

K260179VITA Multi-Function Head Brush (TB-2343F, TB-2442F)K252053VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)K183217아이플 헤어 레이저 제거 장치

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