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FDA 510(k)

INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)

K-Number: K950077 · 1995-06-14

ApplicantPar Vision Systems Corp.
Decision Date1995-06-14
Product CodeMMQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) is the device name listed in this FDA 510(k) record. The listed applicant is Par Vision Systems Corp.. It received FDA 510(k) clearance on 1995-06-14 under 510(k) number K950077. The device is classified under product code MMQ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)?

INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) is a medical device that received FDA 510(k) clearance on 1995-06-14. The listed applicant is Par Vision Systems Corp.. The 510(k) number is K950077.

When did INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) receive FDA 510(k) clearance?

INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) received FDA 510(k) clearance on 1995-06-14, under 510(k) number K950077.

Who is the listed applicant for INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)?

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

What is the FDA product code for INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)?

The FDA product code for INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) is MMQ.

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Related Devices (Code: MMQ)

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.

K981665SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICEBio-Medical Sciences, Inc.K964702EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800Euclid Systems Corp.K964891ORBSHOT KERATOMETEROrbtek, Inc.K963762CORNEAL TOPOGRAPHER 200Eclipse Ventures

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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