Cleared Traditional

LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML (K003031) - FDA 510(k) Clearance

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

K003031 · Alpha Vista, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 119
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K003031.
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
K222541 · Bausch & Lomb, Incorporated · Dec 2022
Aqua Naina Plus Sterile Saline Solution
K221263 · Chemtex USA, Inc. · Oct 2022
ABT12 multi-purpose solution
K202932 · Bausch & Lomb, Incorporated · May 2021
OTE MPS 045 Multi-purpose Lens Care Solution
K210051 · Ote North America, LLC · May 2021
Aqua Naina Sterile Saline Solution
K193441 · Chemtex USA, Inc. · May 2020
PuriLens Plus Preservative Free Saline
K200747 · The Lifestyle Company, Inc. · May 2020