510(k) K050213
K050213 is an FDA 510(k) premarket notification submitted by Ciba Vision Corporation for the device "FRESHLOOK ONE-DAY COLOR CONTACT LENS". The FDA issued a decision of Substantially Equivalent on March 28, 2005. The device falls under product code MVN (Lens, Contact, (Disposable)), a Class II device regulated under 21 CFR 886.5925. Ciba Vision Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2005
- Date Received
- January 31, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Contact, (Disposable)
- Device Class
- Class II
- Regulation Number
- 886.5925
- Review Panel
- OP
- Submission Type