Cleared Traditional

MR Q; MR Q SUPINE; MR Q SLT

K232417 · Meridian AG · Ophthalmic
Jan 2024
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K232417 is an FDA 510(k) clearance for the MR Q; MR Q SUPINE; MR Q SLT, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Meridian AG (Thun, CH). The FDA issued a Cleared decision on January 25, 2024, 167 days after receiving the submission on August 11, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K232417 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2023
Decision Date January 25, 2024
Days to Decision 167 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