FDA 510(k)

OPHTHALMIC SURGICAL SYSTEM

K-Number: K935223 · 1994-03-14

Decision Date1994-03-14

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

OPHTHALMIC SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Optical Micro Systems, Inc.. It received FDA 510(k) clearance on 1994-03-14 under 510(k) number K935223. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHALMIC SURGICAL SYSTEM?

OPHTHALMIC SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1994-03-14. The listed applicant is Optical Micro Systems, Inc.. The 510(k) number is K935223.

When did OPHTHALMIC SURGICAL SYSTEM receive FDA 510(k) clearance?

OPHTHALMIC SURGICAL SYSTEM received FDA 510(k) clearance on 1994-03-14, under 510(k) number K935223.

Who is the listed applicant for OPHTHALMIC SURGICAL SYSTEM?

The FDA 510(k) record lists Optical Micro Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPHTHALMIC SURGICAL SYSTEM?

The FDA product code for OPHTHALMIC SURGICAL SYSTEM is HQC.

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Related Devices (Code: HQC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.