ABT12 multi-purpose solution
FDA 510(k) K202932 · Bausch & Lomb, Incorporated
510(k) numberK202932
Submission
- Device name
- ABT12 multi-purpose solution
- Applicant
- Bausch & Lomb, Incorporated
Rochester, NY, US - Received
- September 29, 2020
- Decision date
- May 28, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPN – Accessories, Soft Lens Products
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5928
- Specialty
- Ophthalmic
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| K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionLPN · Traditional | Menicon Co, Ltd. | 08/13/2026SE |
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting DropsLPN · Traditional | Bausch & Lomb, Incorporated | 12/06/2022SE |
| K221263 | Aqua Naina Plus Sterile Saline SolutionLPN · Special | Chemtex USA, Inc. | 10/12/2022SE |
| K210051 | OTE MPS 045 Multi-purpose Lens Care SolutionLPN · Traditional | Ote North America, LLC | 05/26/2021SE |
| K193441 | Aqua Naina Sterile Saline SolutionLPN · Traditional | Chemtex USA, Inc. | 05/26/2020SE |
| K200747 | PuriLens Plus Preservative Free SalineLPN · Traditional | The Lifestyle Company, Inc. | 05/15/2020SE |
| K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionLPN · Traditional | Menicon Co, Ltd. | 03/02/2020SE |
| K190674 | REFRESH RELIEVA For CONTACTSLPN · Traditional | Allergan, Inc. | 08/08/2019SE |
| K191795 | AOCup Lens Case with AODiscLPN · Special | Alcon Laboratories, Inc. | 07/31/2019SE |
| K170483 | Bausch + Lomb Sensitive Eyes Plus Saline SolutionLPN · Traditional | Bausch & Lomb, Incorporated | 04/11/2017SE |
More from Bausch & Lomb, Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K242389 | EyeGility Inserter for Preloaded enVista IOLsMSS · Traditional | 10/10/2024SE |
| K220613 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon…LPL · Traditional | 03/08/2023SE |
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting DropsLPN · Traditional | 12/06/2022SE |
| K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for PresbyopiaLPL · Traditional | 05/24/2021SE |
| K200416 | Boston One Step Liquid Enzymatic CleanerMRC · Traditional | 09/23/2020SE |
| K192005 | Bausch + Lomb PreVue Inserter for enVista PreloadedMSS · Special | 10/04/2019SE |
| K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B)…HQD · Traditional | 02/12/2019SE |
| K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact LensLPL · Traditional | 11/30/2018SE |
| K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid…MRC · Traditional | 08/10/2018SE |
| K173480 | Crystalsert Lens Delivery SystemMSS · Special | 12/11/2017SE |
Questions and answers
When was ABT12 multi-purpose solution cleared by the FDA?
ABT12 multi-purpose solution (K202932) received a 510(k) decision of Substantially Equivalent on May 28, 2021, 241 days after the submission was received.
What is the product code of K202932?
The FDA product code is LPN – Accessories, Soft Lens Products, a Class II (moderate risk) device regulated under 21 CFR 886.5928.