510(k) K110835
K110835 is an FDA 510(k) premarket notification submitted by GEO MEDICAL CO., LTD. for the device "GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS". The FDA issued a decision of Substantially Equivalent on Apr 26, 2012. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. GEO MEDICAL CO., LTD. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 26, 2012
- Date Received
- Mar 25, 2011
- 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)