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510(k) K250495

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

K250495 is an FDA 510(k) premarket notification submitted by Avizor S.A. for the device "MINI VP1 (PL67_F); MINI VP1 (PL61_F)". The FDA issued a decision of Substantially Equivalent on August 1, 2025. 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
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

Other clearances for product code LRX

  • K252175 — LANDR Contact LENS Case (February 10, 2026)
  • K240095 — CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) (October 9, 2024)
  • K231123 — Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Cas (August 30, 2023)
  • K173538 — Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc (December 4, 2017)
  • K172925 — Contact Lens Case, Model: A-1, B-1 (November 30, 2017)
  • K173365 — Bausch + Lomb Boston Scleral Lens Case (November 17, 2017)
  • K171539 — Contact Lens Case (July 14, 2017)
  • K171163 — Contact Lens Case Round Glasses (June 27, 2017)
  • K162869 — Contact Lens Case (December 9, 2016)
  • K160005 — Contact Lens Case (multiple brand name) (June 7, 2016)

FDA data resources