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510(k) K122700

PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES by Prosben, Inc. — Product Code LRX

K122700 is an FDA 510(k) premarket notification submitted by Prosben, Inc. for the device "PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES". The FDA issued a decision of Substantially Equivalent on May 31, 2013. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2013
Date Received
September 4, 2012
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

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FDA data resources