Cleared Traditional

KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES

K140362 · Katalyst Surgical, LLC · Ophthalmic

Sep 2014

Decision

215d

Days

Class 2

Risk

About This 510(k) Submission

K140362 is an FDA 510(k) clearance for the KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Katalyst Surgical, LLC (Chesterfield, US). The FDA issued a Cleared decision on September 15, 2014, 215 days after receiving the submission on February 12, 2014. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K140362 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 2014
Decision Date	September 15, 2014
Days to Decision	215 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF