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FDA 510(k)

CELALUX 3

K-Number: K153018 · 2016-06-23

ApplicantVoco GmbH
Decision Date2016-06-23
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CELALUX 3 is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K153018. 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 CELALUX 3?

CELALUX 3 is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Voco GmbH. The 510(k) number is K153018.

When did CELALUX 3 receive FDA 510(k) clearance?

CELALUX 3 received FDA 510(k) clearance on 2016-06-23, under 510(k) number K153018.

Who is the listed applicant for CELALUX 3?

The FDA 510(k) record lists Voco GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CELALUX 3?

The FDA product code for CELALUX 3 is EBZ.

Other records listing Voco GmbH 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.

View all 29 devices →

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.