Epic 10 Diode Laser System 7400042

GUDID 00647529000168

A surgical and therapeutic device intended for a variety of soft-tissue procedures, laser-assisted tooth whitening and for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two 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.

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Primary Device ID00647529000168
NIH Device Record Keyce3e89b5-96fa-4c70-a77a-f0bb226ae8ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameEpic 10 Diode Laser System
Version Model Number7400042
Catalog Number7400042
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
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
GS100647529000168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


[00647529000168]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-08
Device Publish Date2016-09-15

On-Brand Devices [Epic 10 Diode Laser System]

00647529002452A dental diode laser system intended for a variety of soft-tissue procedures, laser-assisted too
00647529000168A surgical and therapeutic device intended for a variety of soft-tissue procedures, laser-assist

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