Waterlase Express All-Tissue Laser System 7210001P

GUDID 00647529003466

An all-tissue dental laser system intended for a variety of oral soft-tissue and hard-tissue procedures. The system includes a top-table laser console with a removable tablet PC as a control panel/user interface, a wireless footswitch and a delivery system comprising of a fiber optic cable, two handpieces and a variety of laser tips. Other system components include protective eyewear, power cords, a tip cleaning kit, tablet protective covers, water reservoir fill kit, etc. The patient-contacting components of the delivery system require sterilization prior to use.

Biolase, Inc.

Dental solid-state laser system

Primary Device ID	00647529003466
NIH Device Record Key	cfd78dc1-f4db-49c3-a100-f808dc7ac7e2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Waterlase Express All-Tissue Laser System
Version Model Number	Waterlase Express laser refurbished
Catalog Number	7210001P
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 Temperature	Between 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Temperature	Between 5 Degrees Celsius and 45 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00647529003466 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K161669

FDA Product Code

GEX	Powered Laser Surgical Instrument