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FDA 510(k)

OPTO HYALUS GREEN LASER

K-Number: K111460 · 2012-08-20

ApplicantOpto Eletronica S/A
Decision Date2012-08-20
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTO HYALUS GREEN LASER is the device name listed in this FDA 510(k) record. The listed applicant is Opto Eletronica S/A. It received FDA 510(k) clearance on 2012-08-20 under 510(k) number K111460. 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 HYALUS GREEN LASER?

OPTO HYALUS GREEN LASER is a medical device that received FDA 510(k) clearance on 2012-08-20. The listed applicant is Opto Eletronica S/A. The 510(k) number is K111460.

When did OPTO HYALUS GREEN LASER receive FDA 510(k) clearance?

OPTO HYALUS GREEN LASER received FDA 510(k) clearance on 2012-08-20, under 510(k) number K111460.

Who is the listed applicant for OPTO HYALUS GREEN LASER?

The FDA 510(k) record lists Opto Eletronica S/A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTO HYALUS GREEN LASER?

The FDA product code for OPTO HYALUS GREEN 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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