Cleared Traditional

VISULAS yag

K230350 · Carl Zeiss Meditec, Inc. · Ophthalmic
Sep 2023
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K230350 is an FDA 510(k) clearance for the VISULAS yag, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Carl Zeiss Meditec, Inc. (Dublic, US). The FDA issued a Cleared decision on September 22, 2023, 225 days after receiving the submission on February 9, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K230350 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2023
Decision Date September 22, 2023
Days to Decision 225 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