WAVE ANALYZER MEDICA 800

GUDID 03615020000458

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

ESSILOR INTERNATIONAL

Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser Corneal topography system analyser

• Primary Device ID: 03615020000458
• NIH Device Record Key: f07bcc0c-5977-4bab-8ccf-539d76e891fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WAVE ANALYZER MEDICA 800
• Version Model Number: WAM800
• Company DUNS: 277373213
• Company Name: ESSILOR INTERNATIONAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com
• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com
• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com
• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com
• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com
• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com
• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com
• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com
• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com
• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com
• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com
• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com
• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com
• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com
• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com
• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com
• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com
• Phone: 817-262-3801
• Email: John.Anderson@essilorusa.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03615020000458 [Primary]

FDA Product Code

• HKX: Tonometer, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-02
• Device Publish Date: 2023-07-25

Devices Manufactured by ESSILOR INTERNATIONAL

• 03615020000038 - ALM500: 2023-10-11 This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed l
• 03615020000120 - ALM700: 2023-10-11 This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed l
• 03615020000236 - ALM800: 2023-10-11 This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed l
• 03615020000670 - Vision-C 600: 2023-10-06 Vision-C 600 (VRS001) is a visual chart system, stand-alone type, which displays broad range of charts, based on LCD panel.
• 03615020000427 - Vision-R 800: 2023-09-19 Vision-R 800 is intended to perform a subjective assessment of ametropia or visual function capability
• 03615020000663 - Vision-R 700: 2023-09-19 Vision-R 700 is intended to perform a subjective assessment of ametropia or visual function capability
• 03615020000687 - Vision-S 700: 2023-09-19 Vision-S 700 is a Compact Refraction System used to determine the refractive error and binocular
• 03615020000694 - Vision-R 800: 2023-09-19 Vision-R 800 is intended to perform a subjective assessment of ametropia or visual function capability