CONTACT LASER & DIAGNOSTIC LENSES
FDA 510(k) clearance K023221 · decided 2002-10-11
Clearance details
- K-number
- K023221
- Device name
- CONTACT LASER & DIAGNOSTIC LENSES
- Applicant
- Volk Optical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-27
- Decision date
- 2002-10-11
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- HJK
- Device class
- 2
- Regulation number
- 886.1385
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk O recall (Z-1685-2015) | Volk Optical Inc | 2015-05-28 |