WAVE ANALYZER MEDICA 800

Basic Information

• Brand Name: WAVE ANALYZER MEDICA 800
• Primary DI: 03615020000458
• Version / Model: WAM800
• Company Name: ESSILOR INTERNATIONAL
• Labeler DUNS: 277373213
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-25
• Public Version: 1
• Public Version Date: 2023-08-02
• Public Version Status: New
• Public Device Record Key: f07bcc0c-5977-4bab-8ccf-539d76e891fc

Device Description

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKX	Tonometer, Ac-Powered	Ophthalmic	886.1930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active
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.	No	Active
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.	No	Active
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.	No	Active
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03615020000458	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity