cleadew GP hydra one
FDA 510(k) K251876 · Ophtecs Corporation
510(k) numberK251876
Submission
- Device name
- cleadew GP hydra one
- Applicant
- Ophtecs Corporation
Kobe, JP - Received
- June 18, 2025
- Decision date
- October 9, 2025
- 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
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|---|---|---|---|
| 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 |
| 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 cleadew GP hydra one cleared by the FDA?
cleadew GP hydra one (K251876) received a 510(k) decision of Substantially Equivalent on October 9, 2025, 113 days after the submission was received.
What is the product code of K251876?
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.