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FDA 510(k)

Opera Lebody (Gold), Opera Lebody (Zafiro)

N.º K: K201107 · 2020-06-22

SolicitanteGtg Wellness Co., Ltd.
Fecha de decisión2020-06-22
Código de productoOHS
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Opera Lebody (Gold), Opera Lebody (Zafiro) is the device name listed in this FDA 510(k) record. The listed applicant is Gtg Wellness Co., Ltd.. It received FDA 510(k) clearance on 2020-06-22 under 510(k) number K201107. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Opera Lebody (Gold), Opera Lebody (Zafiro)?

Opera Lebody (Gold), Opera Lebody (Zafiro) is a medical device that received FDA 510(k) clearance on 2020-06-22. The listed applicant is Gtg Wellness Co., Ltd.. The 510(k) number is K201107.

When did Opera Lebody (Gold), Opera Lebody (Zafiro) receive FDA 510(k) clearance?

Opera Lebody (Gold), Opera Lebody (Zafiro) received FDA 510(k) clearance on 2020-06-22, under 510(k) number K201107.

Who is the listed applicant for Opera Lebody (Gold), Opera Lebody (Zafiro)?

The FDA 510(k) record lists Gtg Wellness Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Opera Lebody (Gold), Opera Lebody (Zafiro)?

The FDA product code for Opera Lebody (Gold), Opera Lebody (Zafiro) is OHS.

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Fuente oficial

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