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FDA 510(k)

LED Curing Lights (DB686 HALO)

K-Number: K243921 · 2025-04-11

Decision Date2025-04-11
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LED Curing Lights (DB686 HALO) is a medical device manufactured by Foshan Coxo Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-04-11 under approval number K243921. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LED Curing Lights (DB686 HALO)?

LED Curing Lights (DB686 HALO) is a medical device that received FDA 510(k) clearance on 2025-04-11. It is manufactured by Foshan Coxo Medical Instrument Co., Ltd.. The 510(k) number is K243921.

When was LED Curing Lights (DB686 HALO) approved by the FDA?

LED Curing Lights (DB686 HALO) received FDA 510(k) clearance on 2025-04-11, under approval number K243921.

What company makes LED Curing Lights (DB686 HALO)?

LED Curing Lights (DB686 HALO) is manufactured by Foshan Coxo Medical Instrument Co., Ltd..

What is the FDA product code for LED Curing Lights (DB686 HALO)?

The FDA product code for LED Curing Lights (DB686 HALO) is EBZ.

Other Devices by Foshan Coxo Medical Instrument Co., Ltd.

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Related Devices (Code: EBZ)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.