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FDA 510(k)

7 Series Phototherapy Device

K-Number: K212510 · 2021-11-04

ApplicantDaavlin Distributing Co.
Decision Date2021-11-04
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

7 Series Phototherapy Device is a medical device manufactured by Daavlin Distributing Co.. It received FDA 510(k) clearance on 2021-11-04 under approval number K212510. 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 7 Series Phototherapy Device?

7 Series Phototherapy Device is a medical device that received FDA 510(k) clearance on 2021-11-04. It is manufactured by Daavlin Distributing Co.. The 510(k) number is K212510.

When was 7 Series Phototherapy Device approved by the FDA?

7 Series Phototherapy Device received FDA 510(k) clearance on 2021-11-04, under approval number K212510.

What company makes 7 Series Phototherapy Device?

7 Series Phototherapy Device is manufactured by Daavlin Distributing Co..

What is the FDA product code for 7 Series Phototherapy Device?

The FDA product code for 7 Series Phototherapy Device is FTC.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025)

Other Devices by Daavlin Distributing Co.

K210881M Series Phototherapy Equipment K2208401 Series Phototherapy Equipment K233811DT Controlled Phototherapy Equipment K2303823 Series NeoLux

Related Devices (Code: FTC)

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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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