Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ABT12 multi-purpose solution

K-Number: K202932 · 2021-05-28

ApplicantBausch & Lomb, Incorporated
Decision Date2021-05-28
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ABT12 multi-purpose solution is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Incorporated. It received FDA 510(k) clearance on 2021-05-28 under 510(k) number K202932. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABT12 multi-purpose solution?

ABT12 multi-purpose solution is a medical device that received FDA 510(k) clearance on 2021-05-28. The listed applicant is Bausch & Lomb, Incorporated. The 510(k) number is K202932.

When did ABT12 multi-purpose solution receive FDA 510(k) clearance?

ABT12 multi-purpose solution received FDA 510(k) clearance on 2021-05-28, under 510(k) number K202932.

Who is the listed applicant for ABT12 multi-purpose solution?

The FDA 510(k) record lists Bausch & Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABT12 multi-purpose solution?

The FDA product code for ABT12 multi-purpose solution is LPN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04840563Surface Refractive Index Shift of Kalifilcon A Compared With Dailies Total1 and Precision1 LensesCOMPLETEDNCT05129488Biotrue ONEday Contact Lenses With EPG03 Packaging Solution Compared to Biotrue ONEday Contact LensesCOMPLETEDNCT053259311-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for PresbyopiaCOMPLETEDNCT060537361-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact LensesCOMPLETEDNCT06333015Study to Evaluate the Safety and Effectiveness of the enVista® Beyond (EY) EDF Intraocular Lens in Subjects Undergoing Cataract ExtractionCOMPLETEDNCT06479148Clinical Evaluation of the Performance of the enVista® Aspire™ (EA) LensTERMINATED

Other records listing Bausch & Lomb, Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P240005Lens, multifocal intraocularPMA P910056intraocular lensPMA P910071Fluid, intraocularPMA P860022Lens, contact (rigid gas permeable), extended wearPMA P010062Lens, contact, orthokeratology, overnightPMA N16895Lenses, soft contact, extended wear

View all 38 devices →

Related Devices (Code: LPN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd.K222541Bausch + Lomb Preservative Free Lubricating and Rewetting DropsBausch & Lomb, IncorporatedK221263Aqua Naina Plus Sterile Saline SolutionChemtex USA, Inc.K210051OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLCK193441Aqua Naina Sterile Saline SolutionChemtex USA, Inc.K200747PuriLens Plus Preservative Free SalineThe Lifestyle Company, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑