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FDA 510(k)

Curing Light, Model: MaxCure 9

K-Number: K223414 · 2023-11-15

Decision Date2023-11-15
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Curing Light, Model: MaxCure 9 is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Refine Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2023-11-15 under 510(k) number K223414. 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 Curing Light, Model: MaxCure 9?

Curing Light, Model: MaxCure 9 is a medical device that received FDA 510(k) clearance on 2023-11-15. The listed applicant is Guilin Refine Medical Instrument Co., Ltd.. The 510(k) number is K223414.

When did Curing Light, Model: MaxCure 9 receive FDA 510(k) clearance?

Curing Light, Model: MaxCure 9 received FDA 510(k) clearance on 2023-11-15, under 510(k) number K223414.

Who is the listed applicant for Curing Light, Model: MaxCure 9?

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

What is the FDA product code for Curing Light, Model: MaxCure 9?

The FDA product code for Curing Light, Model: MaxCure 9 is EBZ.

Other records listing Guilin Refine Medical Instrument Co., Ltd. as applicant

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.

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.

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.