510(k) K142717

Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case by Ni Hau Industrial Co., Ltd. — Product Code LRX

K142717 is an FDA 510(k) premarket notification submitted by Ni Hau Industrial Co., Ltd. for the device "Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case". The FDA issued a decision of Substantially Equivalent on May 7, 2015. 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 7, 2015
Date Received
September 23, 2014
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