Identity
- Trade Name
- Pentacam AXL Wave EUDAMEDFDA UDI
- Generic Name
- Corneal topography system FDA UDI
- Device Name
- Pentacam EUDAMEDWhile rotating around the eye, the Pentacam AXL Wave captures Scheimpflug images of the anterior eye segment through varying axes to evaluate several parameters of the cornea, pupil, anterior chamber and lens. The axial length of the eye is measured and displayed by interferometry. Wavefront measurement uses a Hartmann Shack aberrometer to detect the low and high order aberrations of the entire eye. FDA UDI
- Model / Reference
- 70020 EUDAMEDFDA UDI
- Description
- While rotating around the eye, the Pentacam AXL Wave captures Scheimpflug images of the anterior eye segment through varying axes to evaluate several parameters of the cornea, pupil, anterior chamber and lens. The axial length of the eye is measured and displayed by interferometry. Wavefront measurement uses a Hartmann Shack aberrometer to detect the low and high order aberrations of the entire eye. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049584025357 EUDAMEDFDA UDI
- Basic UDI-DI
- 40495846BL EUDAMED
- 510(k) Number
- K201724 FDA UDI
- FDA Product Code
- MXK FDA UDIHJO FDA UDI
- EMDN Code
- Z12120123 COMPUTERISED CORNEAL TOPOGRAPHS EUDAMED
- GMDN Term
- Corneal topography system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1850 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Pentacam AXL Wave by OCULUS Optikgeräte GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201724 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K152311 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 40495846BL | Class IIa | Active |
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Manufacturer
- Manufacturer
- OCULUS Optikgeräte GmbH
- EUDAMED SRN
- DE-MF-000012227
Sources (3)
- EUDAMED 1cc610c0-6633-40a7-8d31-46b054e570a2 61 fields · synced Jun 19, 2026
- FDA UDI 84db981e-f343-47bc-8732-6690f24eb8aa 34 fields · synced May 30, 2026
- FDA 510(k) K201724 1 fields · synced May 18, 2026