FDA 510(k)

Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)

Número K: K251000 · 2025-06-30

RequerenteShenzhen Chuangtong Yigou Technology Co., Ltd.

Data da decisão2025-06-30

Código do produtoOHT

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Chuangtong Yigou Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-06-30 under 510(k) number K251000. 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 Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)?

Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) is a medical device that received FDA 510(k) clearance on 2025-06-30. The listed applicant is Shenzhen Chuangtong Yigou Technology Co., Ltd.. The 510(k) number is K251000.

When did Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) receive FDA 510(k) clearance?

Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) received FDA 510(k) clearance on 2025-06-30, under 510(k) number K251000.

Who is the listed applicant for Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)?

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

What is the FDA product code for Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)?

The FDA product code for Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) is OHT.

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Outros registros que listam Shenzhen Chuangtong Yigou Technology Co., Ltd. como candidato(a)

K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)K254047Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)

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Fonte oficial

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