WaveLight

GUDID 00380659982989

WAVELIGHT FS200 PATIENT INTERFACE - EASYPACK (BOX OF 20)

Alcon Laboratories, Inc.

Ophthalmic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00380659982989
• NIH Device Record Key: 8bda8e8e-3f9c-409d-a4ac-8a3a5a4cc050
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WaveLight
• Version Model Number: 8065998298
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, Inc.
• Device Count: 20
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380659982989 [Primary]
GS1	00380659982996 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190392

FDA Product Code

• GEX: Powered laser surgical instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-05-15

On-Brand Devices [WaveLight]

• 00380659909634: WL ANALYZER II-USA
• 00380659909412: WAVELIGHT FS200
• 10380659908191: Wavelight FS200 Patient intereface
• 00380659982989: WAVELIGHT FS200 PATIENT INTERFACE - EASYPACK (BOX OF 20)
• 00380659906503: Wavelight Lift Table Diagnostic