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FDA 510(k)

OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450

K-Number: K053475 · 2006-03-03

ApplicantRefractec, Inc.
Decision Date2006-03-03
Product CodeHMR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 is the device name listed in this FDA 510(k) record. The listed applicant is Refractec, Inc.. It received FDA 510(k) clearance on 2006-03-03 under 510(k) number K053475. The device is classified under product code HMR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450?

OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 is a medical device that received FDA 510(k) clearance on 2006-03-03. The listed applicant is Refractec, Inc.. The 510(k) number is K053475.

When did OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 receive FDA 510(k) clearance?

OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 received FDA 510(k) clearance on 2006-03-03, under 510(k) number K053475.

Who is the listed applicant for OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450?

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

What is the FDA product code for OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450?

The FDA product code for OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 is HMR.

Related Clinical Trials

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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Other records listing Refractec, Inc. 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.

K980522REFRACTEC MCS-100

Related Devices (Code: HMR)

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.

K925606OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERSChiron Vision Corp.K872747LASER CENTERING DEVICEInnomed Corp.K863663OPHTHALMIC SURGICAL OCULAR MARKERSMyocure, Inc.K861535OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNUCooperVision, Inc.

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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