Cleared Traditional

K980591 - RENU MULTIPLUS LUBRICATING & REWETTING DROPS

K980591 is an FDA 510(k) clearance for RENU MULTIPLUS LUBRICATING & REWETTING ..., 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 127-day FDA review.

K980591 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Jun 1998
Decision
127d
Days
Class 2
Risk

K980591 is an FDA 510(k) clearance for the RENU MULTIPLUS LUBRICATING & REWETTING DROPS. 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 June 24, 1998 after a review of 127 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 Bausch & Lomb, Inc. devices

FDA 510(k) Submission Details - K980591

510(k) Number K980591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1998
Decision Date June 24, 1998
Days to Decision 127 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
17d slower than avg
Panel avg: 110d · This submission: 127d
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 K980591.
LIQUID ENZYME ID 90133
K981561 · Alcon Laboratories · Jul 1998
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K980775 · Allergan, Inc. · Jul 1998
OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION
K981574 · Alcon · Jul 1998
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING, CONDITIONING AND DISINFECTING SOLUTION ID 84392
K981151 · Alcon Laboratories · Jun 1998
YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION
K980147 · Automatic Liquid Packaging, Inc. · Apr 1998
BAUSCH & LOMB WETTING AND SOAKING SOLUTION
K980133 · Polymer Technology Corp. · Mar 1998