Cleared Traditional

K003031 - LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML

K003031 is an FDA 510(k) clearance for LENSOCLEAN MULTI-PURPOSE SOLUTION, manufactured by Alpha Vista, Inc.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K003031 · Alpha Vista, Inc. · Ophthalmic device
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Jan 2001
Decision
99d
Days
Class 2
Risk

K003031 is an FDA 510(k) clearance for the LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Alpha Vista, Inc. (Novata, US). The FDA issued a Cleared decision on January 5, 2001 after a review of 99 days - within the typical 510(k) review window.

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 Alpha Vista, Inc. devices

FDA 510(k) Submission Details - K003031

510(k) Number K003031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2000
Decision Date January 05, 2001
Days to Decision 99 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 110d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPN Device Classification - Class 2, Special Controls

Product Code LPN Accessories, Soft Lens Products
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 - LPN Accessories, Soft Lens Products

All 84
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K003031.
RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION
K011796 · Bausch & Lomb, Inc. · Nov 2001
AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION
K003345 · Ciba Vision Corporation · Mar 2001
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K003252 · Allergan, Inc. · Feb 2001
COMPLETE BRAND LUBRICATING AND REWETTING DROPS
K003109 · Allergan, Inc. · Nov 2000
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
K002823 · Bausch & Lomb, Inc. · Oct 2000
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K001539 · Bausch & Lomb, Inc. · Jul 2000