Epic Pro Diode Laser System 7410001

GUDID 00647529002605

A laser system intended for a variety of surgical and oral soft-tissue procedures and dental tooth whitening. 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, protective eyewear, screen protectors, tip holders). The patient-contacting components of the delivery system require sterilization prior to use.

BIOLASE, INC.

Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system Dental diode laser system
Primary Device ID00647529002605
NIH Device Record Key28af54a3-8058-4fef-bfb6-8d27f161e952
Commercial Distribution StatusIn Commercial Distribution
Brand NameEpic Pro Diode Laser System
Version Model Number7410001
Catalog Number7410001
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 Kittrue
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
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
GS100647529002605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


[00647529002605]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-08
Device Publish Date2017-01-13

On-Brand Devices [Epic Pro Diode Laser System]

00647529003541A 940nm laser system intended for a variety of surgical and oral soft-tissue procedures and dent
00647529002605A laser system intended for a variety of surgical and oral soft-tissue procedures and dental too
00647529003558A 940nm laser system intended for a variety of surgical and oral soft-tissue procedures and dent
00647529003473A laser system intended for a variety of surgical and oral soft-tissue procedures and dental too

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