Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions
FDA 510(k) K173089 · Bausch & Lomb, Incorporated
510(k) numberK173089
Submission
- Device name
- Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions
- Applicant
- Bausch & Lomb, Incorporated
Rochester, NY, US - Received
- September 29, 2017
- Decision date
- November 27, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRC – Products, Contact Lens Care, Rigid Gas Permeable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5918
- Specialty
- Ophthalmic
Other 510(k)s with product code MRC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251876 | cleadew GP hydra oneMRC · Traditional | Ophtecs Corporation | 10/09/2025SE |
| K200416 | Boston One Step Liquid Enzymatic CleanerMRC · Traditional | Bausch & Lomb, Incorporated | 09/23/2020SE |
| K201069 | VibrantVue Scleral SalineMRC · Traditional | Dry Eye Innovations, LLC | 07/31/2020SE |
| K182984 | MaxiTears Contacts PFMRC · Traditional | Omnivision AG | 07/24/2019SE |
| K181566 | NutrifillMRC · Traditional | Contamac, Ltd. | 10/22/2018SE |
| K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid…MRC · Traditional | Bausch & Lomb, Incorporated | 08/10/2018SE |
| K180319 | Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning SolutionMRC · Traditional | Bausch and Lomb, Incorporated | 03/27/2018SE |
| K173136 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensesMRC · Traditional | Menicon Co, Ltd. | 11/16/2017SE |
| K130805 | Menicon Unique PH Multi-Purpose SolutionMRC · Traditional | Menicon Co, Ltd. | 07/03/2013SE |
| K122273 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensMRC · Abbreviated | Menicon Co, Ltd. | 01/02/2013SE |
More from Menicon Co, Ltd.
| 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 |
| K202932 | ABT12 multi-purpose solutionLPN · Traditional | 05/28/2021SE |
| 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 |
Questions and answers
When was Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions cleared by the FDA?
Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions (K173089) received a 510(k) decision of Substantially Equivalent on November 27, 2017, 59 days after the submission was received.
What is the product code of K173089?
The FDA product code is MRC – Products, Contact Lens Care, Rigid Gas Permeable, a Class II (moderate risk) device regulated under 21 CFR 886.5918.