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FDA 510(k)

OPTO MITRA YELLOW LASER

K-Number: K111643 · 2011-11-03

ApplicantOpto Electronica SA
Decision Date2011-11-03
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTO MITRA YELLOW LASER is the device name listed in this FDA 510(k) record. The listed applicant is Opto Electronica SA. It received FDA 510(k) clearance on 2011-11-03 under 510(k) number K111643. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTO MITRA YELLOW LASER?

OPTO MITRA YELLOW LASER is a medical device that received FDA 510(k) clearance on 2011-11-03. The listed applicant is Opto Electronica SA. The 510(k) number is K111643.

When did OPTO MITRA YELLOW LASER receive FDA 510(k) clearance?

OPTO MITRA YELLOW LASER received FDA 510(k) clearance on 2011-11-03, under 510(k) number K111643.

Who is the listed applicant for OPTO MITRA YELLOW LASER?

The FDA 510(k) record lists Opto Electronica SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTO MITRA YELLOW LASER?

The FDA product code for OPTO MITRA YELLOW LASER is HQF.

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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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