FDA 510(k)

LED PHOTIC System

K-Number: K211974 · 2021-09-23

Decision Date2021-09-23

Product CodeGWE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

LED PHOTIC System is the device name listed in this FDA 510(k) record. The listed applicant is Micromed S.P.A.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K211974. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LED PHOTIC System?

LED PHOTIC System is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Micromed S.P.A.. The 510(k) number is K211974.

When did LED PHOTIC System receive FDA 510(k) clearance?

LED PHOTIC System received FDA 510(k) clearance on 2021-09-23, under 510(k) number K211974.

Who is the listed applicant for LED PHOTIC System?

The FDA 510(k) record lists Micromed S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED PHOTIC System?

The FDA product code for LED PHOTIC System is GWE.

Other records listing Micromed S.P.A. 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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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.