510(k) K171163

Contact Lens Case Round Glasses by Fiftytwoways, Ltd. — Product Code LRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2017
Date Received
April 20, 2017
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