Cleared Traditional

MINI VP1 (PL67_F); MINI VP1 (PL61_F)

K250495 · Avizor S.A. · Ophthalmic
Aug 2025
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K250495 is an FDA 510(k) clearance for the MINI VP1 (PL67_F); MINI VP1 (PL61_F), a Case, Contact Lens (Class II — Special Controls, product code LRX), submitted by Avizor S.A. (Legan?s, ES). The FDA issued a Cleared decision on August 1, 2025, 162 days after receiving the submission on February 20, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K250495 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2025
Decision Date August 01, 2025
Days to Decision 162 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LRX — Case, Contact Lens
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5928

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