iLase Diode Laser System 7400040-01

GUDID 00647529002322

iLase Diode Laser System is designed for a variety of dental soft tissue procedures. The iLase system consists of one iLase handpiece and the iLase charging station used for charging and storing the handpiece and replacement batteries. Other systems components include protective eyewear, rechargeable batteries, charging station power supply, handpiece cover grips, laser tips and a tip cleaning kit. The handpiece is a reusable device with a removable cover which requires sterilization prior to each patient use.

BIOLASE, INC.

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Primary Device ID00647529002322
NIH Device Record Key68e91b11-15a4-40ed-81d5-6fb79c37efbb
Commercial Distribution StatusIn Commercial Distribution
Brand NameiLase Diode Laser System
Version Model NumberiLase
Catalog Number7400040-01
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
GS100647529002322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


[00647529002322]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-11-08
Device Publish Date2016-09-22

On-Brand Devices [iLase Diode Laser System]

00647529002322iLase Diode Laser System is designed for a variety of dental soft tissue procedures. The iLase
00647529001332A diode laser system designed for a variety of dental soft tissue procedures. The system consis

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