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FDA 510(k)

Leaf Photocoagulator

K-Number: K190083 · 2019-05-03

ApplicantNorlase Aps
Decision Date2019-05-03
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Leaf Photocoagulator is a medical device manufactured by Norlase Aps. It received FDA 510(k) clearance on 2019-05-03 under approval number K190083. 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 Leaf Photocoagulator?

Leaf Photocoagulator is a medical device that received FDA 510(k) clearance on 2019-05-03. It is manufactured by Norlase Aps. The 510(k) number is K190083.

When was Leaf Photocoagulator approved by the FDA?

Leaf Photocoagulator received FDA 510(k) clearance on 2019-05-03, under approval number K190083.

What company makes Leaf Photocoagulator?

Leaf Photocoagulator is manufactured by Norlase Aps.

What is the FDA product code for Leaf Photocoagulator?

The FDA product code for Leaf Photocoagulator is HQF.

Other Devices by Norlase Aps

K201623LION Photocoagulator K242397LYNX Photocoagulator

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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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