Waterlase Laser Tips 6200224

GUDID 00647529000922

A single-use fiberoptic accessory intended for use with Waterlase Laser delivery systems.

Biolase, Inc.

Dental solid-state laser system
Primary Device ID00647529000922
NIH Device Record Key40b5894b-8949-4f2b-86b0-0eb8b61305a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameWaterlase Laser Tips
Version Model NumberMZ6-12
Catalog Number6200224
Company DUNS152165700
Company NameBiolase, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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 Dimensions

Outer Diameter600 Micrometer
Length12 Millimeter
Outer Diameter600 Micrometer
Length12 Millimeter
Outer Diameter600 Micrometer
Length12 Millimeter
Outer Diameter600 Micrometer
Length12 Millimeter
Outer Diameter600 Micrometer
Length12 Millimeter
Outer Diameter600 Micrometer
Length12 Millimeter
Outer Diameter600 Micrometer
Length12 Millimeter
Outer Diameter600 Micrometer
Length12 Millimeter
Outer Diameter600 Micrometer
Length12 Millimeter
Outer Diameter600 Micrometer
Length12 Millimeter
Outer Diameter600 Micrometer
Length12 Millimeter
Outer Diameter600 Micrometer
Length12 Millimeter
Outer Diameter600 Micrometer
Length12 Millimeter
Outer Diameter600 Micrometer
Length12 Millimeter
Outer Diameter600 Micrometer
Length12 Millimeter
Outer Diameter600 Micrometer
Length12 Millimeter
Outer Diameter600 Micrometer
Length12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100647529000922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00647529000922]

Moist Heat or Steam Sterilization


[00647529000922]

Moist Heat or Steam Sterilization


[00647529000922]

Moist Heat or Steam Sterilization


[00647529000922]

Moist Heat or Steam Sterilization


[00647529000922]

Moist Heat or Steam Sterilization


[00647529000922]

Moist Heat or Steam Sterilization


[00647529000922]

Moist Heat or Steam Sterilization


[00647529000922]

Moist Heat or Steam Sterilization


[00647529000922]

Moist Heat or Steam Sterilization


[00647529000922]

Moist Heat or Steam Sterilization


[00647529000922]

Moist Heat or Steam Sterilization


[00647529000922]

Moist Heat or Steam Sterilization


[00647529000922]

Moist Heat or Steam Sterilization


[00647529000922]

Moist Heat or Steam Sterilization


[00647529000922]

Moist Heat or Steam Sterilization


[00647529000922]

Moist Heat or Steam Sterilization


[00647529000922]

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 Laser Tips ]

00647529003626A reusable fiberoptic tip accessory intended for use with Waterlase All-Tissue Laser Systems.
00647529003503A starter kit containing 14 different laser tips intended for use with Waterlase laser delivery
00647529003459A reusable fiberoptic tip accessory intended for use with Waterlase laser delivery systems.
00647529003152A tip starter kit containing 5 different single-use tips intended for use with Waterlase laser d
00647529003022A tip kit containing 2 reusable sapphire tips intended for use with Waterlase laser delivery sys
00647529002995A tip kit containing 2 reusable sapphire tips, type C, intended for use with Waterlase laser de
00647529002971A tip kit containing 3 reusable sapphire tips intended for use with Waterlase laser delivery sy
00647529002964A Z3 tip kit containing 5 single-use tips intended for use with Waterlase laser delivery systems
00647529002957A Z2 tip kit containing 5 single-use tips intended for use with Waterlase laser delivery system
00647529002940A training kit containing 11 different laser tips intended for use with Waterlase laser delivery
00647529001523A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529001622A tip kit containing 2 reusable laser tips intended for use with Waterlase laser systems. The t
00647529001615A tip kit containing 2 reusable laser tips intended for use with Waterlase laser delivery system
00647529001578A tip starter kit containing 2 single-use RFPT tips intended for use with Waterlase laser delive
00647529001653A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529002933A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529002988A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529002926A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529002919A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529002902A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529002896A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529002889A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529002872A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529001387A Z4 tip kit containing 5 single-use tips intended for use with Waterlase laser delivery system
00647529001370A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529002841A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529001325A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529001318A reusable fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529003091A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529003084A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529003077A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529003060A single-use laser tip intended for use with Waterlase Laser Systems.
00647529003053A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529003046A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529003039A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529002827A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529002810A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529002803A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529000243A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529002797A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529002780A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529001172A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529002766A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529001165A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529001134A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529002742A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529001110A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529002681A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
00647529001097A tip kit containing 20 single-use MZ Zip tips intended for use with Waterlase laser delivery s
00647529001080A tip training kit containing 25 different laser tips intended for use with Waterlase laser deli

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.