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FDA 510(k)

LED Curing Lights (DB686 HALO)

K-Number: K243921 · 2025-04-11

ApplicantFoshan Coxo Medical Instrument Co., Ltd.
Decision Date2025-04-11
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LED Curing Lights (DB686 HALO) is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Coxo Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) 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. The listed applicant is Foshan Coxo Medical Instrument Co., Ltd.. The 510(k) number is K243921.

When did LED Curing Lights (DB686 HALO) receive FDA 510(k) clearance?

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

Who is the listed applicant for LED Curing Lights (DB686 HALO)?

The FDA 510(k) record lists Foshan Coxo Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Foshan Coxo Medical Instrument Co., Ltd. as applicant

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Related Devices (Code: EBZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd.K253461Demi ProMeta Systems Co., Ltd.K242386BluemoonGenoss Co., Ltd.K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) LimitedK241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLCK223414Curing Light, Model: MaxCure 9Guilin Refine Medical Instrument Co., Ltd.

Official Source

View on FDA Database →

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

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