Cleared Traditional

LYNX Photocoagulator

K242397 · Norlase Aps · Ophthalmic
Oct 2024
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K242397 is an FDA 510(k) clearance for the LYNX Photocoagulator, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Norlase Aps (Ballerup, DK). The FDA issued a Cleared decision on October 25, 2024, 73 days after receiving the submission on August 13, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K242397 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2024
Decision Date October 25, 2024
Days to Decision 73 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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