FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
MYAH
K Number: K222933
·
Decision Jun 29, 2023
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
22
Applicant Total
4
Review Days
276
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MYAH
- K Number
- K222933
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Visia Imaging S.R.L.
- Date Received
- September 26, 2022
- Decision Date
- June 29, 2023
- Product Code
- MXK
- 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 |
|---|---|---|---|
| MXK | Device, Analysis, Anterior Segment | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MXK), ordered by most recent decision date.
Pentacam® Cornea OCT
FDA 510(k)
FDA Class 2
·Ophthalmic
Tomey Optical Biometer OA-2000 (OA-2000)
FDA 510(k)
FDA Class 2
·Ophthalmic
BOSS
FDA 510(k)
FDA Class 2
·Ophthalmic
MYAH
FDA 510(k)
FDA Class 2
·Ophthalmic
Myopia Master
FDA 510(k)
FDA Class 2
·Ophthalmic
Pentacam AXL Wave
FDA 510(k)
FDA Class 2
·Ophthalmic