Epic Hygiene Diode Laser System 7420006

GUDID 00647529004159

A handpiece for a dental 980nm diode laser system intended for a variety of soft-tissue procedures. The dental diode laser 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 foot-switch and other accessories (power cord, protective eyewear, tip holder). The patient-contacting components of the delivery system require sterilization prior to use.

Biolase, Inc.

Dental diode laser system
Primary Device ID00647529004159
NIH Device Record Keye4f3a277-1c16-4927-a0b8-affe4014781b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEpic Hygiene Diode Laser System
Version Model NumberHandpiece, 1pk
Catalog Number7420006
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
GS100647529004159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00647529004159]

Moist Heat or Steam Sterilization


[00647529004159]

Moist Heat or Steam Sterilization


[00647529004159]

Moist Heat or Steam Sterilization


[00647529004159]

Moist Heat or Steam Sterilization


[00647529004159]

Moist Heat or Steam Sterilization


[00647529004159]

Moist Heat or Steam Sterilization


[00647529004159]

Moist Heat or Steam Sterilization


[00647529004159]

Moist Heat or Steam Sterilization


[00647529004159]

Moist Heat or Steam Sterilization


[00647529004159]

Moist Heat or Steam Sterilization


[00647529004159]

Moist Heat or Steam Sterilization


[00647529004159]

Moist Heat or Steam Sterilization


[00647529004159]

Moist Heat or Steam Sterilization


[00647529004159]

Moist Heat or Steam Sterilization


[00647529004159]

Moist Heat or Steam Sterilization


[00647529004159]

Moist Heat or Steam Sterilization


[00647529004159]

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

On-Brand Devices [Epic Hygiene Diode Laser System]

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00647529004166A dental 980nm diode laser system intended for a variety of soft-tissue procedures. The system i
00647529004159A handpiece for a dental 980nm diode laser system intended for a variety of soft-tissue procedur

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