FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
EIDON FA
K Number: K180526
·
Decision Jul 16, 2018
Classifications
1
FEI Numbers
13
Registration Numbers
14
Same Product Code
21
Applicant Total
13
Review Days
139
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Basic Information
- Device Name
- EIDON FA
- K Number
- K180526
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Centervue S.P.A.
- Date Received
- February 27, 2018
- Decision Date
- July 16, 2018
- Product Code
- MYC
- 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 |
|---|---|---|---|
| MYC | Ophthalmoscope, Laser, Scanning | FDA class 2 | Ophthalmic |
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Other Clearances by Centervue S.P.A.
| K Number | Device Name | ||
|---|---|---|---|
| K243504 | MAIA (AHMACME001) | Mar 17, 2025 | Substantially Equivalent |
| K234076 | iCare ALTIUS CW | Aug 22, 2024 | Substantially Equivalent |
| K213705 | DRSplus | Dec 21, 2021 | Substantially Equivalent |
| K211328 | EIDON FA, EIDON, EIDON AF, EIDON UWFL | Aug 19, 2021 | Substantially Equivalent |
| K192113 | DRSplus | Nov 15, 2019 | Substantially Equivalent |
| K180293 | Retia 2 | May 30, 2018 | Substantially Equivalent |
| K153181 | MAIA | Jun 8, 2016 | Substantially Equivalent |
| K150320 | COMPASS | Jun 30, 2015 | Substantially Equivalent |
| K142047 | EIDON | Nov 12, 2014 | Substantially Equivalent |
| K133758 | CENTERVUE MACULAR INTEGRITY ASSESSMENT | Apr 23, 2014 | Substantially Equivalent |