Cleared Traditional

K202932 - ABT12 multi-purpose solution (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

K202932 · Bausch & Lomb, Incorporated · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
241d
Days
Class 2
Risk

K202932 is an FDA 510(k) clearance for the ABT12 multi-purpose solution. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Bausch & Lomb, Incorporated (Rochester, US). The FDA issued a Cleared decision on May 28, 2021 after a review of 241 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, Incorporated devices

Submission Details

510(k) Number K202932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2020
Decision Date May 28, 2021
Days to Decision 241 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
131d slower than avg
Panel avg: 110d · This submission: 241d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03897751 Completed Interventional Industry-sponsored

A Safety and Effectiveness Study of BL-ABT12 Multi-Purpose Solution for Use by Participants With Soft Contact Lenses

A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution

252
Patients (actual)
17
Sites
Supportive_care
Purpose
Double blind
Masking
Condition studied Contact Lens Wear
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Johnson Varughese
Sponsor Bausch & Lomb Incorporated (industry)
Started 2019-03-08 → Primary completion 2019-08-01
Primary outcome
Overall Comfort
View full study on ClinicalTrials.gov