FDA 510(k)

Eye Recovery Pro (PH-e03)

Número K: K261602 · 2026-08-10

RequerenteShenzhen Goodwind Technology Development Co., Ltd.

Data da decisão2026-08-10

Código do produtoOHS

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Eye Recovery Pro (PH-e03) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Goodwind Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2026-08-10 under 510(k) number K261602. 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 Eye Recovery Pro (PH-e03)?

Eye Recovery Pro (PH-e03) is a medical device that received FDA 510(k) clearance on 2026-08-10. The listed applicant is Shenzhen Goodwind Technology Development Co., Ltd.. The 510(k) number is K261602.

When did Eye Recovery Pro (PH-e03) receive FDA 510(k) clearance?

Eye Recovery Pro (PH-e03) received FDA 510(k) clearance on 2026-08-10, under 510(k) number K261602.

Who is the listed applicant for Eye Recovery Pro (PH-e03)?

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

What is the FDA product code for Eye Recovery Pro (PH-e03)?

The FDA product code for Eye Recovery Pro (PH-e03) 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 Goodwind Technology Development Co., Ltd. como candidato(a)

K252983Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)K222316IPL Hair Removal Device

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.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 K2605985 Wavelength LED Facemask (TN2508)iSMART Developments, Ltd.

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.