510(k) K200747

PuriLens Plus Preservative Free Saline by The Lifestyle Company, Inc. — Product Code LPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2020
Date Received
March 23, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Soft Lens Products
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type