510(k) K051477
K051477 is an FDA 510(k) premarket notification submitted by Mi Gwang Contact Lens Co., Ltd. for the device "MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC)". The FDA issued a decision of Substantially Equivalent on Mar 10, 2006. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 10, 2006
- Date Received
- Jun 3, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Lenses, Soft Contact, Daily Wear
- Device Class
- Class II
- Regulation Number
- 886.5925
- Review Panel
- OP
- Submission Type
- 510(k)