Cleared Traditional

K983225 - BAUSCH & LOMB RENU EFFERVESCENT ENZYMAT...

K983225 is the FDA 510(k) clearance for BAUSCH & LOMB RENU EFFERVESCENT ENZYMAT... by Bausch & Lomb, Inc.. It is a Class 2 Ophthalmic device (product code LPN) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K983225 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
196d
Days
Class 2
Risk

K983225 is an FDA 510(k) clearance for the BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER. 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 March 29, 1999 after a review of 196 days - an extended review 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: 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

Submission Details

510(k) Number K983225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1998
Decision Date March 29, 1999
Days to Decision 196 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
86d slower than avg
Panel avg: 110d · This submission: 196d
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 K983225.
OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP
K984573 · Alcon Laboratories · Sep 1999
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
K990480 · Alcon Laboratories · May 1999
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K990422 · Bausch & Lomb, Inc. · Apr 1999
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