Waterlase iPlus Dental Laser System 7200854-11

GUDID 00647529000083

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 (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use.

BIOLASE, INC.

Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system Dental solid-state laser system
Primary Device ID00647529000083
NIH Device Record Keyd7e86177-de05-467c-89be-b97a5a9f610b
Commercial Distribution StatusIn Commercial Distribution
Brand NameWaterlase iPlus Dental Laser System
Version Model Number7200854-11
Catalog Number7200854-11
Company DUNS152165700
Company NameBIOLASE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100647529000083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


[00647529000083]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

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00647529003879An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedur
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