Cleared Traditional

K982775 - BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION

K982775 is the FDA 510(k) clearance for BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION by Bausch & Lomb, Inc.. It is a Class 2 Ophthalmic device (product code LPN) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K982775 · Bausch & Lomb, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Nov 1998
Decision
88d
Days
Class 2
Risk

K982775 is an FDA 510(k) clearance for the BAUSCH & LOMB RENU 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 November 3, 1998 after a review of 88 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

Submission Details

510(k) Number K982775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1998
Decision Date November 03, 1998
Days to Decision 88 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
22d faster than avg
Panel avg: 110d · This submission: 88d
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 35
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K982775.
MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K984575 · Alcon Laboratories · Jan 1999
MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K983780 · Alcon Laboratories · Dec 1998
OPTI-ONE MULTI-PURPOSE SOLUTION
K983973 · Alcon Laboratories · Dec 1998
LIQUID ENZYME ID 90133
K981561 · Alcon Laboratories · Jul 1998
RENU MULTIPLUS LUBRICATING & REWETTING DROPS
K980591 · Bausch & Lomb, Inc. · Jun 1998
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING, CONDITIONING AND DISINFECTING SOLUTION ID 84392
K981151 · Alcon Laboratories · Jun 1998