FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Myopia Master
K Number: K202989
·
Decision Jul 14, 2021
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
20
Applicant Total
1
Review Days
287
Basic Information
- Device Name
- Myopia Master
- K Number
- K202989
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OCULUS Optikgeräte GmbH
- Date Received
- September 30, 2020
- Decision Date
- July 14, 2021
- 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 |
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