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FDA 510(k)

ORBSCAN

K-Number: K984443 · 1999-03-05

ApplicantTechnolas Perfect Vision GmbH
Decision Date1999-03-05
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ORBSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Technolas Perfect Vision GmbH. It received FDA 510(k) clearance on 1999-03-05 under 510(k) number K984443. The device is classified under product code MXK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORBSCAN?

ORBSCAN is a medical device that received FDA 510(k) clearance on 1999-03-05. The listed applicant is Technolas Perfect Vision GmbH. The 510(k) number is K984443.

When did ORBSCAN receive FDA 510(k) clearance?

ORBSCAN received FDA 510(k) clearance on 1999-03-05, under 510(k) number K984443.

Who is the listed applicant for ORBSCAN?

The FDA 510(k) record lists Technolas Perfect Vision GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORBSCAN?

The FDA product code for ORBSCAN is MXK.

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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.

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