510(k) K250495

MINI VP1 (PL67_F); MINI VP1 (PL61_F) by Avizor S.A. — Product Code LRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2025
Date Received
February 20, 2025
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