Cleared Traditional

VISULAS combi

K233911 · Carl Zeiss Meditec, AG · Ophthalmic
Sep 2024
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K233911 is an FDA 510(k) clearance for the VISULAS combi, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on September 6, 2024, 269 days after receiving the submission on December 12, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K233911 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2023
Decision Date September 06, 2024
Days to Decision 269 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