Cleared Traditional

VISULAS green

K181682 · Carl Zeiss Meditec, AG · Ophthalmic
Mar 2019
Decision
253d
Days
Class 2
Risk

About This 510(k) Submission

K181682 is an FDA 510(k) clearance for the VISULAS green, 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 March 6, 2019, 253 days after receiving the submission on June 26, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K181682 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2018
Decision Date March 06, 2019
Days to Decision 253 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