510(k) K130285
K130285 is an FDA 510(k) premarket notification submitted by The Lagado Corp. for the device "PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS". The FDA issued a decision of Substantially Equivalent on April 3, 2013. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. The Lagado Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2013
- Date Received
- February 5, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Case, Contact Lens
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type