FDA 510(k)

LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)

K-Nummer: K253135 · 2025-12-23

AntragstellerDongguan Yijiaming Technology Co., Ltd.

Entscheidungsdatum2025-12-23

ProduktcodeOHS

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Yijiaming Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K253135. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)?

LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Dongguan Yijiaming Technology Co., Ltd.. The 510(k) number is K253135.

When did LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) receive FDA 510(k) clearance?

LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) received FDA 510(k) clearance on 2025-12-23, under 510(k) number K253135.

Who is the listed applicant for LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)?

The FDA 510(k) record lists Dongguan Yijiaming 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 (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)?

The FDA product code for LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) is OHS.

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Verwandte Geräte (Code: OHS)

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