Cleared Traditional

K020802 - RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION

K020802 is an FDA 510(k) clearance for RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION, manufactured by Bausch & Lomb, Incorporated. The device is a Class 2 Ophthalmic device with product code LYL cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K020802 · Bausch & Lomb, Incorporated · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
80d
Days
Class 2
Risk

K020802 is an FDA 510(k) clearance for the RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION. Classified as Accessories, Solution, Ultrasonic Cleaners For Lenses (product code LYL), Class II - Special Controls.

Submitted by Bausch & Lomb, Incorporated (Rochester, US). The FDA issued a Cleared decision on May 31, 2002 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bausch & Lomb, Incorporated devices

FDA 510(k) Submission Details - K020802

510(k) Number K020802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2002
Decision Date May 31, 2002
Days to Decision 80 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
30d faster than avg
Panel avg: 110d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LYL Device Classification - Class 2, Special Controls

Product Code LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
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 - LYL Accessories, Solution, Ultrasonic Cleaners For Lenses

All 10
Devices cleared under the same product code (LYL) and FDA review panel - the closest regulatory comparables to K020802.
VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
K210300 · Vuesonic, LLC · Apr 2021
BPZ02 MULTIPURPOSE SOLUTION
K083757 · Bausch & Lomb, Inc. · Nov 2009
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K022687 · Ciba Vision Corporation · Nov 2002
CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
K994021 · Strieter Clinical Research Laboratories, Inc. · Feb 2000
PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES
K991965 · Purilens, Inc. · Oct 1999
LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY
K982115 · Rim-Wide Companies, Inc. · Jan 1999