510(k) K130285

PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS by The Lagado Corp. — Product Code LRX

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