Pentacam AXL Wave

GUDID 04049584025357

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.

OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

Corneal topography system
Primary Device ID04049584025357
NIH Device Record Key84db981e-f343-47bc-8732-6690f24eb8aa
Commercial Distribution StatusIn Commercial Distribution
Brand NamePentacam AXL Wave
Version Model Number70020
Company DUNS317138956
Company NameOCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104049584025357 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MXKDevice, Analysis, Anterior Segment

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-11
Device Publish Date2021-11-03

Devices Manufactured by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung

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04049584001450 - BK 1/W, coated, wall version, trial lens case2024-09-12 BK 1/W, coated, wall version, trial lens case
04049584001467 - BK 1/W, without convex cylinders, wall version, trial lens case2024-09-12 BK 1/W, without convex cylinders, wall version, trial lens case
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04049584001498 - BK 2, coated, wooden case with handle2024-09-12 BK 2, coated, wooden case with handle
04049584001511 - BK 2, without convex cylinders, wooden case with handle2024-09-12 BK 2, without convex cylinders, wooden case with handle
04049584001528 - BK 2, without convex cylinders, coated,wooden case with handle2024-09-12 BK 2, without convex cylinders, coated,wooden case with handle

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