Cleared Special

VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D

K050623 · Volk Optical, Inc. · Ophthalmic

Mar 2005

Decision

18d

Days

Class 2

Risk

About This 510(k) Submission

K050623 is an FDA 510(k) clearance for the VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D, a Lens, Contact, Polymethylmethacrylate, Diagnostic (Class II — Special Controls, product code HJK), submitted by Volk Optical, Inc. (Rockville, US). The FDA issued a Cleared decision on March 28, 2005, 18 days after receiving the submission on March 10, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number	K050623 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2005
Decision Date	March 28, 2005
Days to Decision	18 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF