Waterlase Laser System Turbo Handpiece

GUDID 00647529002469

A reusable handpiece intended for use with Waterlase laser systems.

BIOLASE, INC.

Dental solid-state laser system
Primary Device ID00647529002469
NIH Device Record Keya1208805-8b8d-40ed-8939-2588f1abf6ac
Commercial Distribution Discontinuation2018-08-10
Commercial Distribution StatusNot in Commercial Distribution
Brand NameWaterlase Laser System Turbo Handpiece
Version Model Number6201126 Refurbished
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 Datefalse
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
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com
Phone1-800-321-6717
EmailWaterlaseservice@biolase.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100647529002469 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


[00647529002469]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-08-10
Device Publish Date2016-09-15

On-Brand Devices [Waterlase Laser System Turbo Handpiece ]

00647529002469A reusable handpiece intended for use with Waterlase laser systems.
00647529002285A reusable handpiece intended for use with Waterlase laser systems.

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