FDA 510(k)

Intense Pulse Light Therapeutic Apparatus

N.º K: K232932 · 2023-12-04

SolicitanteShenzhen Greatro Electronic Technology Co., Ltd.

Fecha de decisión2023-12-04

Código de productoOHT

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Intense Pulse Light Therapeutic Apparatus is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Greatro Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-04 under 510(k) number K232932. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Intense Pulse Light Therapeutic Apparatus?

Intense Pulse Light Therapeutic Apparatus is a medical device that received FDA 510(k) clearance on 2023-12-04. The listed applicant is Shenzhen Greatro Electronic Technology Co., Ltd.. The 510(k) number is K232932.

When did Intense Pulse Light Therapeutic Apparatus receive FDA 510(k) clearance?

Intense Pulse Light Therapeutic Apparatus received FDA 510(k) clearance on 2023-12-04, under 510(k) number K232932.

Who is the listed applicant for Intense Pulse Light Therapeutic Apparatus?

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

What is the FDA product code for Intense Pulse Light Therapeutic Apparatus?

The FDA product code for Intense Pulse Light Therapeutic Apparatus is OHT.

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Otros registros que enlistan a Shenzhen Greatro Electronic Technology Co., Ltd. como solicitante

K242595Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)

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