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FDA 510(k)

PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS

K-Number: K073477 · 2008-05-09

ApplicantPhotonova Ofsweden AB
Decision Date2008-05-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Photonova Ofsweden AB. It received FDA 510(k) clearance on 2008-05-09 under 510(k) number K073477. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS?

PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS is a medical device that received FDA 510(k) clearance on 2008-05-09. The listed applicant is Photonova Ofsweden AB. The 510(k) number is K073477.

When did PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS receive FDA 510(k) clearance?

PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS received FDA 510(k) clearance on 2008-05-09, under 510(k) number K073477.

Who is the listed applicant for PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS?

The FDA 510(k) record lists Photonova Ofsweden AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS?

The FDA product code for PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS is GEX. This falls under the Gastroenterology category.

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Official Source

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