Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

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

N.º K: K213039 · 2022-05-25

SolicitanteLi-Tek Electronics Technology C0., Ltd.
Fecha de decisión2022-05-25
Código de productoOLP
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

↑