WaveLight

Basic Information

• Brand Name: WaveLight
• Primary DI: 00380659906503
• Version / Model: 8065990650
• Company Name: Alcon Laboratories, Inc.
• Labeler DUNS: 008018525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-03
• Public Version: 2
• Public Version Date: 2021-08-09
• Public Version Status: Update
• Public Device Record Key: def98295-87b5-4a7e-8b83-415b4637a755

Device Description

Wavelight Lift Table Diagnostic

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: Yes
• 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
HRJ	Table, instrument, powered, ophthalmic	Ophthalmic	886.4855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
39659	Static ophthalmic equipment stand, electrically-adjusted	An electrically-powered device designed as a column or post, usually with a small flat surface top, used to provide support and position control for ophthalmic devices commonly used during an ophthalmic examination/treatment (e.g., a slit lamp, keratometer, refractometer). It typically has a powered height adjustment function enabling the clinician to align (raise/lower) the ophthalmic instruments to the eye level of the patient. It is typically stationary and may have drawers, shelves, and built-in outlets to supply low-voltage electricity to the instruments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380659906503	GS1

Customer Contacts

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