510(k) K023221
K023221 is an FDA 510(k) premarket notification submitted by Volk Optical, Inc. for the device "CONTACT LASER & DIAGNOSTIC LENSES". The FDA issued a decision of Substantially Equivalent on October 11, 2002. The device falls under product code HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic), a Class II device regulated under 21 CFR 886.1385. Volk Optical, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 11, 2002
- Date Received
- September 27, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Contact, Polymethylmethacrylate, Diagnostic
- Device Class
- Class II
- Regulation Number
- 886.1385
- Review Panel
- OP
- Submission Type