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)

Micro-current facial cold and hot service (model: TPML-100)

Número K: K213039 · 2022-05-25

RequerenteLi-Tek Electronics Technology C0., Ltd.
Data da decisão2022-05-25
Código do produtoOLP
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Micro-current facial cold and hot service (model: TPML-100) is the device name listed in this FDA 510(k) record. The listed applicant is Li-Tek Electronics Technology C0., Ltd.. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K213039. 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 Micro-current facial cold and hot service (model: TPML-100)?

Micro-current facial cold and hot service (model: TPML-100) is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Li-Tek Electronics Technology C0., Ltd.. The 510(k) number is K213039.

When did Micro-current facial cold and hot service (model: TPML-100) receive FDA 510(k) clearance?

Micro-current facial cold and hot service (model: TPML-100) received FDA 510(k) clearance on 2022-05-25, under 510(k) number K213039.

Who is the listed applicant for Micro-current facial cold and hot service (model: TPML-100)?

The FDA 510(k) record lists Li-Tek Electronics Technology C0., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Micro-current facial cold and hot service (model: TPML-100)?

The FDA product code for Micro-current facial cold and hot service (model: TPML-100) 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.

↑