Waterlase Express Handpiece 7220001P

GUDID 00647529003480

A reusable handpiece intended for use with the Waterlase Express Laser System in a variety of dental hard-tissue and soft-tissue procedures.

Biolase, Inc.

Dental solid-state laser system
Primary Device ID00647529003480
NIH Device Record Key9b8381dd-cfc7-4147-ab6b-b0dcadc89445
Commercial Distribution StatusIn Commercial Distribution
Brand NameWaterlase Express Handpiece
Version Model NumberHandpiece, 1PK, refurbished
Catalog Number7220001P
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100647529003480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00647529003480]

Moist Heat or Steam Sterilization


[00647529003480]

Moist Heat or Steam Sterilization


[00647529003480]

Moist Heat or Steam Sterilization


[00647529003480]

Moist Heat or Steam Sterilization


[00647529003480]

Moist Heat or Steam Sterilization


[00647529003480]

Moist Heat or Steam Sterilization


[00647529003480]

Moist Heat or Steam Sterilization


[00647529003480]

Moist Heat or Steam Sterilization


[00647529003480]

Moist Heat or Steam Sterilization


[00647529003480]

Moist Heat or Steam Sterilization


[00647529003480]

Moist Heat or Steam Sterilization


[00647529003480]

Moist Heat or Steam Sterilization


[00647529003480]

Moist Heat or Steam Sterilization


[00647529003480]

Moist Heat or Steam Sterilization


[00647529003480]

Moist Heat or Steam Sterilization


[00647529003480]

Moist Heat or Steam Sterilization


[00647529003480]

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 [Waterlase Express Handpiece ]

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00647529003480A reusable handpiece intended for use with the Waterlase Express Laser System in a variety of de
00647529001509A reusable handpiece intended for use with the Waterlase Express Laser System in a variety of de

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