FDA 510(k)

KALA Red Light Face Mask (KALA-01)

Número K: K250581 · 2025-05-30

RequerenteShenzhen Kaiyan Medical Equipment Co., Ltd.

Data da decisão2025-05-30

Código do produtoOHS

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

KALA Red Light Face Mask (KALA-01) 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 2025-05-30 under 510(k) number K250581. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the KALA Red Light Face Mask (KALA-01)?

KALA Red Light Face Mask (KALA-01) is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K250581.

When did KALA Red Light Face Mask (KALA-01) receive FDA 510(k) clearance?

KALA Red Light Face Mask (KALA-01) received FDA 510(k) clearance on 2025-05-30, under 510(k) number K250581.

Who is the listed applicant for KALA Red Light Face Mask (KALA-01)?

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 KALA Red Light Face Mask (KALA-01)?

The FDA product code for KALA Red Light Face Mask (KALA-01) is OHS.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Shenzhen Kaiyan Medical Equipment Co., Ltd. como candidato(a)

K253932FACEGYM Pro Device (HD-109)K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)K252603HIGHERDOSE Body Sculptor (Modelo: GS-03)

Ver todos os 24 dispositivos →

Dispositivos Relacionados (Código: 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

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.