MaxiTears Contacts PF
FDA 510(k) K182984 · Omnivision AG
510(k) numberK182984
Submission
- Device name
- MaxiTears Contacts PF
- Applicant
- Omnivision AG
Neuhausen Am Rheinfall, CH - Received
- October 29, 2018
- Decision date
- July 24, 2019
- 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
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| 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 |
| K173089 | Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning…MRC · Traditional | Bausch & Lomb, Incorporated | 11/27/2017SE |
| 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 |
Questions and answers
When was MaxiTears Contacts PF cleared by the FDA?
MaxiTears Contacts PF (K182984) received a 510(k) decision of Substantially Equivalent on July 24, 2019, 268 days after the submission was received.
What is the product code of K182984?
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.