FDA 510(k)

Intense Pulsed Light (IPL) System

Número K: K212881 · 2022-04-11

RequerenteShenzhen Fansizhe Science and Technology Co., Ltd.

Data da decisão2022-04-11

Código do produtoOHT

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Intense Pulsed Light (IPL) System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Fansizhe Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-04-11 under 510(k) number K212881. 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 (IPL) System?

Intense Pulsed Light (IPL) System is a medical device that received FDA 510(k) clearance on 2022-04-11. The listed applicant is Shenzhen Fansizhe Science and Technology Co., Ltd.. The 510(k) number is K212881.

When did Intense Pulsed Light (IPL) System receive FDA 510(k) clearance?

Intense Pulsed Light (IPL) System received FDA 510(k) clearance on 2022-04-11, under 510(k) number K212881.

Who is the listed applicant for Intense Pulsed Light (IPL) System?

The FDA 510(k) record lists Shenzhen Fansizhe Science and 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 (IPL) System?

The FDA product code for Intense Pulsed Light (IPL) System is OHT.

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Outros registros que listam Shenzhen Fansizhe Science and Technology Co., Ltd. como candidato(a)

K253881Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)K251173Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)K223928Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K K221569Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K

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