FDA 510(k)

LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)

K-Nummer: K254025 · 2026-06-16

AntragstellerShenzhen Kaiyan Medical Equipment Co., Ltd.

Entscheidungsdatum2026-06-16

ProduktcodeOHS

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K254025. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)?

LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K254025.

When did LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) receive FDA 510(k) clearance?

LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) received FDA 510(k) clearance on 2026-06-16, under 510(k) number K254025.

Who is the listed applicant for LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)?

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

What is the FDA product code for LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)?

The FDA product code for LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) is OHS.

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Verwandte Geräte (Code: OHS)

K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)Kam Yuen Plastic Products , Ltd.K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)Shenzhen Qianyu Technology Co., Ltd.K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC

Offizielle Quelle

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