Cleared Traditional

CATARHEX 3

K133562 · Oertli Instrumente AG · Ophthalmic

Aug 2014

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K133562 is an FDA 510(k) clearance for the CATARHEX 3, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Oertli Instrumente AG (Berneck, CH). The FDA issued a Cleared decision on August 12, 2014, 265 days after receiving the submission on November 20, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number	K133562 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2013
Decision Date	August 12, 2014
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF