Waterlase MDX 450 Laser System

GUDID 00647529003282

An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories. The patient-contacting components of the delivery system require sterilization prior to use.

Biolase, Inc.

Dental solid-state laser system

Primary Device ID	00647529003282
NIH Device Record Key	ff8a5530-dcb4-48df-9c5e-0472900f84d6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Waterlase MDX 450 Laser System
Version Model Number	7200860-01P Certified Preowned
Company DUNS	152165700
Company Name	Biolase, Inc.
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	1-800-321-6717
Email	Waterlaseservice@biolase.com
Phone	1-800-321-6717
Email	Waterlaseservice@biolase.com
Phone	1-800-321-6717
Email	Waterlaseservice@biolase.com
Phone	1-800-321-6717
Email	Waterlaseservice@biolase.com
Phone	1-800-321-6717
Email	Waterlaseservice@biolase.com
Phone	1-800-321-6717
Email	Waterlaseservice@biolase.com
Phone	1-800-321-6717
Email	Waterlaseservice@biolase.com
Phone	1-800-321-6717
Email	Waterlaseservice@biolase.com
Phone	1-800-321-6717
Email	Waterlaseservice@biolase.com
Phone	1-800-321-6717
Email	Waterlaseservice@biolase.com
Phone	1-800-321-6717
Email	Waterlaseservice@biolase.com
Phone	1-800-321-6717
Email	Waterlaseservice@biolase.com
Phone	1-800-321-6717
Email	Waterlaseservice@biolase.com
Phone	1-800-321-6717
Email	Waterlaseservice@biolase.com
Phone	1-800-321-6717
Email	Waterlaseservice@biolase.com
Phone	1-800-321-6717
Email	Waterlaseservice@biolase.com
Phone	1-800-321-6717
Email	Waterlaseservice@biolase.com

Operating and Storage Conditions

Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00647529003282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K101658

FDA Product Code

GEX	Powered Laser Surgical Instrument