DEVICE: WAVE ANALYZER MEDICA 800 (03615020000458)
Device Identifier (DI) Information
WAVE ANALYZER MEDICA 800
WAM800
In Commercial Distribution
ESSILOR INTERNATIONAL
WAM800
In Commercial Distribution
ESSILOR INTERNATIONAL
The WAM800 is a multifunctional ophthalmic device. There are several operation modes combined in a single platform :
- Aberrometer
- Autorefractometer keratometer
- Corneal topographer
- Tonometer
- Pachymeter
- Retro-illumination
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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45734 | Corneal topography system analyser |
A mains electricity (AC-powered) ophthalmic device used to measure the curvature and concentricity of the anterior corneal surface. It is typically a dedicated videokeratoscope that uses Placido imaging (involves a disk with concentric white and black rings) to provide keratometric and topographic measurements and images. It will typically output to a dedicated computer workstation or external computer with installed dedicated application software.
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Active | false |
18038 | Corneal topography system |
An assembly of ophthalmic devices used to measure the curvature and concentricity of the anterior corneal surface. It typically consists of a line-powered videokeratoscope using Placido imaging (involves disk with concentric white and black rings), and application software for installation in an included computer workstation, or external computer, for image processing and analysis. This device will be used to evaluate the need for refractive eye surgery, e.g., laser assisted in situ keratomileusis (LASIK) treatment.
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Active | false |
36386 | Automated ophthalmic refractometer |
An electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision.
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Active | false |
12811 | Bench-top keratometer |
A bench-top, mains electricity (AC-powered) ophthalmic instrument designed to measure the curvature of the anterior surface of the cornea, particularly for determining the presence, extent, and axis of astigmatism (an error of refraction in the eye due to the cornea being unequally curved in different directions, so that rays of light in different meridians cannot be brought to focus together on the retina). It actually measures the radius of curvature in millimetres but typically displays it in dioptres. It is used mainly for contact lens fitting and for intraocular lens power determination prior to cataract surgery. This device is also known as an ophthalmometer.
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Active | false |
35399 | Ophthalmic tonometer, line-powered |
An ophthalmic, line-powered, measuring instrument used for determining the intraocular pressure (IOP) by exerting an external force against the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). It typically has no contact with the eye and can use various techniques, e.g., the air-puff tonometer records deflections of the cornea from a puff of pressurized air; the applanation tonometer records the indentation pressure in thousands of a second. It is used for the diagnosis of glaucoma, designed for table top use and may provide the data on a screen and/or a print-out.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HKX | Tonometer, Ac-Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between -40 and 70 Degrees Celsius |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -10 and 55 Degrees Celsius |
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f07bcc0c-5977-4bab-8ccf-539d76e891fc
August 02, 2023
1
July 25, 2023
August 02, 2023
1
July 25, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
817-262-3801
John.Anderson@essilorusa.com
John.Anderson@essilorusa.com