LED PHOTIC System
K-Number: K211974 · 2021-09-23
ApplicantMicromed S.P.A.
Decision Date2021-09-23
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
LED PHOTIC System is a medical device manufactured by Micromed S.P.A.. It received FDA 510(k) clearance on 2021-09-23 under approval 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. It is manufactured by Micromed S.P.A.. The 510(k) number is K211974.
When was LED PHOTIC System approved by the FDA?
LED PHOTIC System received FDA 510(k) clearance on 2021-09-23, under approval number K211974.
What company makes LED PHOTIC System?
LED PHOTIC System is manufactured by Micromed S.P.A..
What is the FDA product code for LED PHOTIC System?
The FDA product code for LED PHOTIC System is GWE.
Other Devices by Micromed S.P.A.
Related Devices (Code: GWE)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.