Cleared Traditional

K002823 - RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION

K002823 is an FDA 510(k) clearance for RENU MULTIPLUS MULTI-PURPOSE DISINFECTI..., manufactured by Bausch & Lomb, Inc.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K002823 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
36d
Days
Class 2
Risk

K002823 is an FDA 510(k) clearance for the RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on October 17, 2000 after a review of 36 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.

FDA 510(k) Submission Details - K002823

510(k) Number K002823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2000
Decision Date October 17, 2000
Days to Decision 36 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
74d faster than avg
Panel avg: 110d · This submission: 36d
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 119
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K002823.
LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML
K003031 · Alpha Vista, Inc. · Jan 2001
COMPLETE BRAND LUBRICATING AND REWETTING DROPS
K003109 · Allergan, Inc. · Nov 2000
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K002589 · Alcon Universal, Ltd. · Oct 2000
PURILENS SALINE SOLUTION
K002319 · Purilens, Inc. · Aug 2000
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K001539 · Bausch & Lomb, Inc. · Jul 2000
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K001214 · Alcon Universal, Ltd. · Jul 2000
K002823 · RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
Download PDF FDA Summary Bausch & Lomb, Inc.