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FDA 510(k)

IRIS MEDICAL IQ 810 PHOTOCOAGULATOR

K-Number: K040209 · 2004-09-20

ApplicantIridex Corp
Decision Date2004-09-20
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IRIS MEDICAL IQ 810 PHOTOCOAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Iridex Corp. It received FDA 510(k) clearance on 2004-09-20 under 510(k) number K040209. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRIS MEDICAL IQ 810 PHOTOCOAGULATOR?

IRIS MEDICAL IQ 810 PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 2004-09-20. The listed applicant is Iridex Corp. The 510(k) number is K040209.

When did IRIS MEDICAL IQ 810 PHOTOCOAGULATOR receive FDA 510(k) clearance?

IRIS MEDICAL IQ 810 PHOTOCOAGULATOR received FDA 510(k) clearance on 2004-09-20, under 510(k) number K040209.

Who is the listed applicant for IRIS MEDICAL IQ 810 PHOTOCOAGULATOR?

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

What is the FDA product code for IRIS MEDICAL IQ 810 PHOTOCOAGULATOR?

The FDA product code for IRIS MEDICAL IQ 810 PHOTOCOAGULATOR is HQF.

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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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