510(k) K981574

OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION by Alcon — Product Code LPN

K981574 is an FDA 510(k) premarket notification submitted by Alcon for the device "OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION". The FDA issued a decision of Substantially Equivalent on July 6, 1998. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928. Alcon has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1998
Date Received
May 4, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Soft Lens Products
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type