Cleared Traditional

K250495 - MINI VP1 (PL67_F) (FDA 510(k) Clearance)

Also includes:
MINI VP1 (PL61_F)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250495 · Avizor S.A. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
162d
Days
Class 2
Risk

K250495 is an FDA 510(k) clearance for the MINI VP1 (PL67_F). Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Avizor S.A. (Leganés, ES). The FDA issued a Cleared decision on August 1, 2025 after a review of 162 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Avizor S.A. devices

Submission Details

510(k) Number K250495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 110d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRX Case, Contact Lens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - LRX Case, Contact Lens

All 81
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K250495.
LANDR Contact LENS Case
K252175 · Fourth Axis, LLC · Feb 2026
CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
K240095 · Shanghai Care US Medical Product Co., Ltd. · Oct 2024
Phoenix Contact Lens Case - dome top flat pack (CL-01)
K231123 · Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. · Aug 2023