K251876
- 510(k) number
- K251876
- Device name
- cleadew GP hydra one
- Applicant
- Ophtecs Corporation JP
- Product code
- MRC — Products, Contact Lens Care, Rigid Gas Permeable
- Decision date
- 2025-10-09
- Date received
- 2025-06-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251876.pdf
Official FDA record: K251876
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.