FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
cleadew GP hydra one
K Number: K251876
·
Decision Oct 9, 2025
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
32
Applicant Total
1
Review Days
113
Basic Information
- Device Name
- cleadew GP hydra one
- K Number
- K251876
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5918
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ophtecs Corporation
- Date Received
- June 18, 2025
- Decision Date
- October 9, 2025
- Product Code
- MRC
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | FDA class 2 | Ophthalmic |
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