Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)

Número K: K161434 · 2017-09-28

RequerenteLi-Tek Electronics Technologies
Data da decisão2017-09-28
Código do produtoOLP
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is the device name listed in this FDA 510(k) record. The listed applicant is Li-Tek Electronics Technologies. It received FDA 510(k) clearance on 2017-09-28 under 510(k) number K161434. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)?

Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is a medical device that received FDA 510(k) clearance on 2017-09-28. The listed applicant is Li-Tek Electronics Technologies. The 510(k) number is K161434.

When did Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) receive FDA 510(k) clearance?

Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) received FDA 510(k) clearance on 2017-09-28, under 510(k) number K161434.

Who is the listed applicant for Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)?

The FDA 510(k) record lists Li-Tek Electronics Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)?

The FDA product code for Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) is OLP.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: OLP)

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.

K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.K251843Erchonia EVRLErchonia CorporationK242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,LtdK243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INTDongguan Hunter Electronic Technology Co., 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.

↑