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FDA 510(k)

LED Therapy Light (COB1400, HP1800PRO)

N.º K: K253874 · 2026-03-03

SolicitanteShenzhen Hanhua Opto Co., Ltd.
Fecha de decisión2026-03-03
Código de productoOHS
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

LED Therapy Light (COB1400, HP1800PRO) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Hanhua Opto Co., Ltd.. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K253874. 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 LED Therapy Light (COB1400, HP1800PRO)?

LED Therapy Light (COB1400, HP1800PRO) is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is Shenzhen Hanhua Opto Co., Ltd.. The 510(k) number is K253874.

When did LED Therapy Light (COB1400, HP1800PRO) receive FDA 510(k) clearance?

LED Therapy Light (COB1400, HP1800PRO) received FDA 510(k) clearance on 2026-03-03, under 510(k) number K253874.

Who is the listed applicant for LED Therapy Light (COB1400, HP1800PRO)?

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

What is the FDA product code for LED Therapy Light (COB1400, HP1800PRO)?

The FDA product code for LED Therapy Light (COB1400, HP1800PRO) is OHS.

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Fuente oficial

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