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FDA 510(k)

PDE PHOTODYNAMIC EYE

K-Number: K110480 · 2012-01-13

ApplicantHamamatsu Photonics K.K.
Decision Date2012-01-13
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PDE PHOTODYNAMIC EYE is the device name listed in this FDA 510(k) record. The listed applicant is Hamamatsu Photonics K.K.. It received FDA 510(k) clearance on 2012-01-13 under 510(k) number K110480. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PDE PHOTODYNAMIC EYE?

PDE PHOTODYNAMIC EYE is a medical device that received FDA 510(k) clearance on 2012-01-13. The listed applicant is Hamamatsu Photonics K.K.. The 510(k) number is K110480.

When did PDE PHOTODYNAMIC EYE receive FDA 510(k) clearance?

PDE PHOTODYNAMIC EYE received FDA 510(k) clearance on 2012-01-13, under 510(k) number K110480.

Who is the listed applicant for PDE PHOTODYNAMIC EYE?

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

What is the FDA product code for PDE PHOTODYNAMIC EYE?

The FDA product code for PDE PHOTODYNAMIC EYE is OWN.

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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.

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