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FDA 510(k)

IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS

K-Number: K031665 · 2003-08-27

ApplicantIridex Corp
Decision Date2003-08-27
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Iridex Corp. It received FDA 510(k) clearance on 2003-08-27 under 510(k) number K031665. 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 OCULIGHT GL/GLX LASER SYSTEMS?

IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS is a medical device that received FDA 510(k) clearance on 2003-08-27. The listed applicant is Iridex Corp. The 510(k) number is K031665.

When did IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS receive FDA 510(k) clearance?

IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS received FDA 510(k) clearance on 2003-08-27, under 510(k) number K031665.

Who is the listed applicant for IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS?

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 OCULIGHT GL/GLX LASER SYSTEMS?

The FDA product code for IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS is HQF.

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Other records listing Iridex Corp 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.

K121475TXCELL SCANNING LASER DELIVERY SYSTEMK071687FAMILI OF IRIDEX IQ LASER SYSTEMSK062074IRIDEX WIRELESS FOOTSWITCHK062369IRIDEX OCULIGHT TXK060905IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1K050562OCULIGHT GL/GLX

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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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