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FDA 510(k)

IPL Hair Removal Device (SYL001AZ, SYL002AZ)

N.º K: K253035 · 2025-11-19

SolicitanteGu'An Yeolight Smart Electronics Co., Ltd.
Fecha de decisión2025-11-19
Código de productoOHT
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

IPL Hair Removal Device (SYL001AZ, SYL002AZ) is the device name listed in this FDA 510(k) record. The listed applicant is Gu'An Yeolight Smart Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-11-19 under 510(k) number K253035. 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 IPL Hair Removal Device (SYL001AZ, SYL002AZ)?

IPL Hair Removal Device (SYL001AZ, SYL002AZ) is a medical device that received FDA 510(k) clearance on 2025-11-19. The listed applicant is Gu'An Yeolight Smart Electronics Co., Ltd.. The 510(k) number is K253035.

When did IPL Hair Removal Device (SYL001AZ, SYL002AZ) receive FDA 510(k) clearance?

IPL Hair Removal Device (SYL001AZ, SYL002AZ) received FDA 510(k) clearance on 2025-11-19, under 510(k) number K253035.

Who is the listed applicant for IPL Hair Removal Device (SYL001AZ, SYL002AZ)?

The FDA 510(k) record lists Gu'An Yeolight Smart Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPL Hair Removal Device (SYL001AZ, SYL002AZ)?

The FDA product code for IPL Hair Removal Device (SYL001AZ, SYL002AZ) is OHT.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: OHT)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K261977Braun Aura 9 (6042)Cyden LimitedK262524Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)ONE BEAUTY Technology Co., Ltd.K261705Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd.K261325Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)Shenzhen Ulike Smart Electronics Co., Ltd.K260594IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)Shenzhen Xiazhifeng Electronic Co., Ltd.K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)Shenzhen Ulike Smart Electronics Co., Ltd.

Fuente oficial

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