FDA 510(k)

LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)

Número K: K261052 · 2026-06-29

RequerenteGuangdong Newdermo Biotech Co., Ltd.

Data da decisão2026-06-29

Código do produtoOHS

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) 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 2026-06-29 under 510(k) number K261052. 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 LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)?

LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) is a medical device that received FDA 510(k) clearance on 2026-06-29. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. The 510(k) number is K261052.

When did LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) receive FDA 510(k) clearance?

LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) received FDA 510(k) clearance on 2026-06-29, under 510(k) number K261052.

Who is the listed applicant for LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)?

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 Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)?

The FDA product code for LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) 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 Guangdong Newdermo Biotech Co., Ltd. como candidato(a)

K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))K260946Máscara de Terapia de Luz LED (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)K260202LED Light Therapy Masks (LumiLips FAC07NA)K223544LED light therapy mask (FM-01, FM-02, FM-03)

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.