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FDA 510(k)

4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES

K-Number: K111172 · 2011-08-29

Decision Date2011-08-29
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Daavlin Distributing Co.. It received FDA 510(k) clearance on 2011-08-29 under 510(k) number K111172. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES?

4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES is a medical device that received FDA 510(k) clearance on 2011-08-29. The listed applicant is Daavlin Distributing Co.. The 510(k) number is K111172.

When did 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES receive FDA 510(k) clearance?

4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES received FDA 510(k) clearance on 2011-08-29, under 510(k) number K111172.

Who is the listed applicant for 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES?

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

What is the FDA product code for 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES?

The FDA product code for 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES is FTC.

Related Clinical Trials

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.

Other records listing Daavlin Distributing Co. 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.

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Related Devices (Code: FTC)

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.

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