FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
Fundus On Phone Non Mydriatic (FOP NM-10)
K Number: K252120
·
Decision Dec 12, 2025
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
155
Applicant Total
1
Review Days
158
Basic Information
- Device Name
- Fundus On Phone Non Mydriatic (FOP NM-10)
- K Number
- K252120
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Remidio Innovative Solutions Private Limited
- Date Received
- July 7, 2025
- Decision Date
- December 12, 2025
- Product Code
- HKI
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HKI), ordered by most recent decision date.
Eyer 2
FDA 510(k)
FDA Class 2
·Ophthalmic
Optina-4C (MHRC-C1N)
FDA 510(k)
FDA Class 2
·Ophthalmic
3nethra neo HD FA; 3nethra neo HD
FDA 510(k)
FDA Class 2
·Ophthalmic
Resolve Fundus Camera
FDA 510(k)
FDA Class 2
·Ophthalmic
Sentinel Camera
FDA 510(k)
FDA Class 2
·Ophthalmic
Verily Numetric Retinal Camera
FDA 510(k)
FDA Class 2
·Ophthalmic