Cleared Traditional

MICRORUPTER V

K023045 · Meridian AG · Ophthalmic
Sep 2002
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K023045 is an FDA 510(k) clearance for the MICRORUPTER V, a Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla (Class II — Special Controls, product code LXS), submitted by Meridian AG (Thun, Bern, CH). The FDA issued a Cleared decision on September 26, 2002, 14 days after receiving the submission on September 12, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4392.

Submission Details

510(k) Number K023045 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2002
Decision Date September 26, 2002
Days to Decision 14 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LXS — Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4392