510(k) K061157

SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS by Bausch & Lomb — Product Code MVN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2006
Date Received
April 26, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact, (Disposable)
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type