Cleared Traditional

K990422 - RENU MULTIPLUS MULTI-PURPOSE SOLUTION

K990422 is an FDA 510(k) clearance for RENU MULTIPLUS MULTI-PURPOSE SOLUTION, 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 75-day FDA review.

K990422 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
75d
Days
Class 2
Risk

K990422 is an FDA 510(k) clearance for the RENU MULTIPLUS MULTI-PURPOSE 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 April 27, 1999 after a review of 75 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, Inc. devices

FDA 510(k) Submission Details - K990422

510(k) Number K990422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1999
Decision Date April 27, 1999
Days to Decision 75 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
35d faster than avg
Panel avg: 110d · This submission: 75d
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 80
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K990422.
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K991403 · Ciba Vision Corporation · Jul 1999
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K990480 · Alcon Laboratories · May 1999
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K983225 · Bausch & Lomb, Inc. · Mar 1999
LOBOB UNIVERSAL CONTACT LENS CLEANER
K990044 · Lobob Laboratories, Inc. · Feb 1999
MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K984575 · Alcon Laboratories · Jan 1999