FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Pentacam AXL
K Number: K152311
·
Decision Jan 20, 2016
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
22
Applicant Total
6
Review Days
159
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Basic Information
- Device Name
- Pentacam AXL
- K Number
- K152311
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1850
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oculus Optikgerate GmbH
- Date Received
- August 14, 2015
- Decision Date
- January 20, 2016
- 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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Other Clearances by Oculus Optikgerate GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K201724 | Pentacam AXL Wave | Oct 21, 2020 | Substantially Equivalent |
| K113066 | CORVIS ST | Nov 8, 2012 | Substantially Equivalent |
| K073508 | PARKONE | Sep 11, 2008 | Substantially Equivalent |
| K041841 | PACHYCAM | Jan 28, 2005 | Substantially Equivalent |
| K030719 | PENTACAM SCHEIMPFLUG CAMERA | Sep 16, 2003 | Substantially Equivalent |