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FDA 510(k)

INTRAORAL LENS OPTION TO SPECTROSHADE

K-Number: K012744 · 2002-01-23

ApplicantMht Optic Research AG
Decision Date2002-01-23
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTRAORAL LENS OPTION TO SPECTROSHADE is the device name listed in this FDA 510(k) record. The listed applicant is Mht Optic Research AG. It received FDA 510(k) clearance on 2002-01-23 under 510(k) number K012744. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAORAL LENS OPTION TO SPECTROSHADE?

INTRAORAL LENS OPTION TO SPECTROSHADE is a medical device that received FDA 510(k) clearance on 2002-01-23. The listed applicant is Mht Optic Research AG. The 510(k) number is K012744.

When did INTRAORAL LENS OPTION TO SPECTROSHADE receive FDA 510(k) clearance?

INTRAORAL LENS OPTION TO SPECTROSHADE received FDA 510(k) clearance on 2002-01-23, under 510(k) number K012744.

Who is the listed applicant for INTRAORAL LENS OPTION TO SPECTROSHADE?

The FDA 510(k) record lists Mht Optic Research AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTRAORAL LENS OPTION TO SPECTROSHADE?

The FDA product code for INTRAORAL LENS OPTION TO SPECTROSHADE is EIA.

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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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