CONTACT LASER & DIAGNOSTIC LENSES


Device Classification Name

lens, contact, polymethylmethacrylate, diagnostic

510(k) Number K023221
Device Name CONTACT LASER & DIAGNOSTIC LENSES
Original Applicant
VOLK OPTICAL, INC.
15825 shady grove rd.
suite 30
rockville, 
MD 
20850

Original Contact richard e lippman
Regulation Number 886.1385
Classification Product Code
HJK  
Date Received 09/27/2002
Decision Date 10/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No