Dental Soft Tissue Laser System 7410008

GUDID 00647529004357

A surgical and therapeutic device intended for a variety of soft-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two surgical handpieces and laser tips, a wireless footswitch and other accessories (power cords, tip holders, protective eyewear, screen protectors). The patient-contacting components of the delivery system require sterilization prior to use.

Biolase, Inc.

Dental diode laser system
Primary Device ID00647529004357
NIH Device Record Keyada4972a-7a0b-4a79-8e6d-a52fd7fe360c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDental Soft Tissue Laser System
Version Model NumberEpic Q Laser System
Catalog Number7410008
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
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100647529004357 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00647529004357]

Moist Heat or Steam Sterilization


[00647529004357]

Moist Heat or Steam Sterilization


[00647529004357]

Moist Heat or Steam Sterilization


[00647529004357]

Moist Heat or Steam Sterilization


[00647529004357]

Moist Heat or Steam Sterilization


[00647529004357]

Moist Heat or Steam Sterilization


[00647529004357]

Moist Heat or Steam Sterilization


[00647529004357]

Moist Heat or Steam Sterilization


[00647529004357]

Moist Heat or Steam Sterilization


[00647529004357]

Moist Heat or Steam Sterilization


[00647529004357]

Moist Heat or Steam Sterilization


[00647529004357]

Moist Heat or Steam Sterilization


[00647529004357]

Moist Heat or Steam Sterilization


[00647529004357]

Moist Heat or Steam Sterilization


[00647529004357]

Moist Heat or Steam Sterilization


[00647529004357]

Moist Heat or Steam Sterilization


[00647529004357]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-27
Device Publish Date2023-06-19

Devices Manufactured by Biolase, Inc.

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00647529003749 - Waterlase Laser Tips2023-08-09 A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529003770 - Waterlase iPlus Dental Laser System2023-08-09 A handpiece utilized with an all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. Th
00647529003787 - Waterlase iPlus Dental Laser System2023-08-09 A kit including a handpiece and tips intended to be utilized with an all-tissue dental laser system intended for a variety of so
00647529000120 - Diode Laser Tips2023-06-27 A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
00647529000137 - Diode Laser Tips2023-06-27 A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.
00647529000687 - Waterlase Laser Tips 2023-06-27 A single-use fiberoptic accessory intended for use with Waterlase Laser delivery systems.
00647529000922 - Waterlase Laser Tips 2023-06-27 A single-use fiberoptic accessory intended for use with Waterlase Laser delivery systems.

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