FDA 510(k)

LED Light Therapy Device (Models: SG-FM, SG-FE)

N.º K: K253086 · 2025-12-19

Fecha de decisión2025-12-19

Código de productoOHS

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

LED Light Therapy Device (Models: SG-FM, SG-FE) is the device name listed in this FDA 510(k) record. The listed applicant is Sunglor Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K253086. 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 Light Therapy Device (Models: SG-FM, SG-FE)?

LED Light Therapy Device (Models: SG-FM, SG-FE) is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Sunglor Technology Co., Ltd.. The 510(k) number is K253086.

When did LED Light Therapy Device (Models: SG-FM, SG-FE) receive FDA 510(k) clearance?

LED Light Therapy Device (Models: SG-FM, SG-FE) received FDA 510(k) clearance on 2025-12-19, under 510(k) number K253086.

Who is the listed applicant for LED Light Therapy Device (Models: SG-FM, SG-FE)?

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

What is the FDA product code for LED Light Therapy Device (Models: SG-FM, SG-FE)?

The FDA product code for LED Light Therapy Device (Models: SG-FM, SG-FE) is OHS.

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Otros registros que enlistan a Sunglor Technology Co., Ltd. como solicitante

K253073LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)

Dispositivos relacionados (Código: OHS)

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Fuente oficial

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