Cleared Traditional

K250495 - MINI VP1 (PL67_F)

Also marketed or referenced as:
MINI VP1 (PL61_F)

K250495 is an FDA 510(k) clearance for MINI VP1 (PL67_F), manufactured by Avizor S.A.. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 162-day FDA review.

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

FDA 510(k) Submission Details - K250495

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.

LRX Device Classification - Class 2, Special Controls

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 13
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
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
K173538 · Alcon Laboratories, Inc. · Dec 2017
Bausch + Lomb Boston Scleral Lens Case
K173365 · Bausch & Lomb, Incorporated · Nov 2017
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
K041820 · Ciba Vision Corporation · Sep 2005