Cleared Traditional

Leaf Photocoagulator

K190083 · Norlase Aps · Ophthalmic
May 2019
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K190083 is an FDA 510(k) clearance for the Leaf Photocoagulator, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Norlase Aps (Ballerup, DK). The FDA issued a Cleared decision on May 3, 2019, 106 days after receiving the submission on January 17, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K190083 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2019
Decision Date May 03, 2019
Days to Decision 106 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQF — Laser, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4390