Cleared Traditional

KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES

K121187 · Katalyst Surgical, LLC · Ophthalmic
Sep 2012
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K121187 is an FDA 510(k) clearance for the KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Katalyst Surgical, LLC (Washington, US). The FDA issued a Cleared decision on September 17, 2012, 151 days after receiving the submission on April 19, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K121187 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2012
Decision Date September 17, 2012
Days to Decision 151 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

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