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FDA 510(k)

IRIDIS OPHTHALMIC PHOTOCOAGULATOR

K-Number: K023094 · 2002-12-17

ApplicantQuantel Medical
Decision Date2002-12-17
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IRIDIS OPHTHALMIC PHOTOCOAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Quantel Medical. It received FDA 510(k) clearance on 2002-12-17 under 510(k) number K023094. 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 IRIDIS OPHTHALMIC PHOTOCOAGULATOR?

IRIDIS OPHTHALMIC PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 2002-12-17. The listed applicant is Quantel Medical. The 510(k) number is K023094.

When did IRIDIS OPHTHALMIC PHOTOCOAGULATOR receive FDA 510(k) clearance?

IRIDIS OPHTHALMIC PHOTOCOAGULATOR received FDA 510(k) clearance on 2002-12-17, under 510(k) number K023094.

Who is the listed applicant for IRIDIS OPHTHALMIC PHOTOCOAGULATOR?

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

What is the FDA product code for IRIDIS OPHTHALMIC PHOTOCOAGULATOR?

The FDA product code for IRIDIS OPHTHALMIC PHOTOCOAGULATOR is HQF.

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Other records listing Quantel Medical as applicant

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Related Devices (Code: HQF)

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.

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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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