510(k) K041820

SOLO-CARE AQUA ANTIMICROBIAL LENS CASE by Ciba Vision Corporation — Product Code LRX

K041820 is an FDA 510(k) premarket notification submitted by Ciba Vision Corporation for the device "SOLO-CARE AQUA ANTIMICROBIAL LENS CASE". The FDA issued a decision of Substantially Equivalent on September 9, 2005. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Ciba Vision Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2005
Date Received
July 6, 2004
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