| K-number | K251876 |
| Device name | cleadew GP hydra one |
| Applicant | Ophtecs Corporation |
| Product code | MRC |
| Device class | Class II |
| Decision date | Oct 9, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 886.5918 |
Cleadew GP hydra one is a sterile, aqueous contact lens care solution for cleaning, removing protein, rinsing, disinfecting, conditioning, and storing fluoro silicone acrylate and silicone acrylate rigid gas permeable (RGP) contact lenses. It is supplied in 360 mL and 60 mL tamper-resistant bottles and is preserved with hydrogen peroxide (0.004%) and polyhexamethylene biguanide hydrochloride (0.0005%).
Cleadew GP hydra one is substantially equivalent to Boston SIMPLUS Multi-Action Solution in intended use, indications for use, actions, classification (21 CFR 886.5918), supply format (sterile, multi-dose), and preservation system. Both are Class II rigid gas permeable contact lens care products with product code MRC, though the formulations differ in specific ingredients.
ISO 11981:2017 (lens compatibility), ISO 18369-4:2017 (extractables testing), ISO 11986:2017 (preservative uptake), Good Laboratory Practices (GLP) for biocompatibility, and microbiological efficacy testing per disinfecting regimen procedures.
View the full FDA submission: accessdata.fda.gov