The following data is part of a premarket notification filed by Volk Optical, Inc. with the FDA for Contact Laser & Diagnostic Lenses.
| Device ID | K023221 |
| 510k Number | K023221 |
| Device Name: | CONTACT LASER & DIAGNOSTIC LENSES |
| Classification | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Applicant | VOLK OPTICAL, INC. 15825 SHADY GROVE RD. SUITE 30 Rockville, MD 20850 |
| Contact | Richard E Lippman |
| Correspondent | Richard E Lippman VOLK OPTICAL, INC. 15825 SHADY GROVE RD. SUITE 30 Rockville, MD 20850 |
| Product Code | HJK |
| CFR Regulation Number | 886.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-27 |
| Decision Date | 2002-10-11 |