Cleared Traditional

K173089 - Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions

K173089 is an FDA 510(k) clearance for Bausch + Lomb Boston Original Cleaner, manufactured by Bausch & Lomb, Incorporated. The device is a Class 2 Ophthalmic device with product code MRC cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K173089 · Bausch & Lomb, Incorporated · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
59d
Days
Class 2
Risk

K173089 is an FDA 510(k) clearance for the Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditio.... Classified as Products, Contact Lens Care, Rigid Gas Permeable (product code MRC), Class II - Special Controls.

Submitted by Bausch & Lomb, Incorporated (Rochester, US). The FDA issued a Cleared decision on November 27, 2017 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5918 - 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, Incorporated devices

FDA 510(k) Submission Details - K173089

510(k) Number K173089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date November 27, 2017
Days to Decision 59 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
51d faster than avg
Panel avg: 110d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRC Device Classification - Class 2, Special Controls

Product Code MRC Products, Contact Lens Care, Rigid Gas Permeable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5918
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 - MRC Products, Contact Lens Care, Rigid Gas Permeable

All 23
Devices cleared under the same product code (MRC) and FDA review panel - the closest regulatory comparables to K173089.
Nutrifill
K181566 · Contamac, Ltd. · Oct 2018
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner
K181627 · Bausch & Lomb, Incorporated · Aug 2018
Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution
K180319 · Bausch and Lomb, Incorporated · Mar 2018
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
K173136 · Menicon Co, Ltd. · Nov 2017
MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
K130805 · Menicon Co, Ltd. · Jul 2013
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
K122273 · Menicon Co, Ltd. · Jan 2013