FDA 510(k)

Leaf Photocoagulator

K-Number: K190083 · 2019-05-03

Decision Date2019-05-03

Product CodeHQF

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Leaf Photocoagulator is the device name listed in this FDA 510(k) record. The listed applicant is Norlase Aps. It received FDA 510(k) clearance on 2019-05-03 under 510(k) 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. The listed applicant is Norlase Aps. The 510(k) number is K190083.

When did Leaf Photocoagulator receive FDA 510(k) clearance?

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

Who is the listed applicant for Leaf Photocoagulator?

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

What is the FDA product code for Leaf Photocoagulator?

The FDA product code for Leaf Photocoagulator is HQF.

Other records listing Norlase Aps as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242397LYNX Photocoagulator K201623LION Photocoagulator

Related Devices (Code: HQF)

K252979Voyager DSLT (430840610)Belkin Vision, Ltd.K251507INTEGRE LIOQuantel Medical K251772Navilas Laser System 577sl (156691)Od-Os GmbH K243014EyeQ nanoECPEyeq, Inc.K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.K242397LYNX PhotocoagulatorNorlase Aps

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.