510(k) K130930

OWL CONTACT LENS CASES, DOG CONTACT LENS CASES by Ningbo Lishunda Electronics Co., Ltd. — Product Code LRX

K130930 is an FDA 510(k) premarket notification submitted by Ningbo Lishunda Electronics Co., Ltd. for the device "OWL CONTACT LENS CASES, DOG CONTACT LENS CASES". The FDA issued a decision of Substantially Equivalent on February 12, 2014. 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
February 12, 2014
Date Received
April 4, 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