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FDA 510(k)

Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.

Número K: K231613 · 2023-07-31

RequerenteZhuzhou Goldenhot Medical Technology Co., Ltd.
Data da decisão2023-07-31
Código do produtoOHT
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. is the device name listed in this FDA 510(k) record. The listed applicant is Zhuzhou Goldenhot Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-07-31 under 510(k) number K231613. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.?

Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. is a medical device that received FDA 510(k) clearance on 2023-07-31. The listed applicant is Zhuzhou Goldenhot Medical Technology Co., Ltd.. The 510(k) number is K231613.

When did Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. receive FDA 510(k) clearance?

Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. received FDA 510(k) clearance on 2023-07-31, under 510(k) number K231613.

Who is the listed applicant for Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.?

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

What is the FDA product code for Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.?

The FDA product code for Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. is OHT.

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Outros registros que listam Zhuzhou Goldenhot Medical Technology Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: OHT)

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Fonte oficial

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