Cleared Traditional

Retina Workplace

K170638 · Carl Zeiss Meditec, AG · Ophthalmic
Jun 2017
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K170638 is an FDA 510(k) clearance for the Retina Workplace, a System, Image Management, Ophthalmic (Class II — Special Controls, product code NFJ), submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on June 21, 2017, 111 days after receiving the submission on March 2, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K170638 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2017
Decision Date June 21, 2017
Days to Decision 111 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code NFJ — System, Image Management, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050