Waterlase Express 7230001
GUDID 00647529003800
A kit composed of single-use fiberoptic accessories intended for use with the Waterlase Express all-tissue dental laser system in soft-tissue and hard-tissue procedures.
Biolase, Inc.
Dental solid-state laser system| Primary Device ID | 00647529003800 |
| NIH Device Record Key | 6c99bf7a-93ea-4106-aadb-b8f4adfd5fd9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Waterlase Express |
| Version Model Number | Waterlase Express Tip Starter Kit, 37pk |
| Catalog Number | 7230001 |
| Company DUNS | 152165700 |
| Company Name | Biolase, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-800-321-6717 |
| Waterlaseservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Waterlaseservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Waterlaseservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Waterlaseservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Waterlaseservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Waterlaseservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Waterlaseservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Waterlaseservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Waterlaseservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Waterlaseservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Waterlaseservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Waterlaseservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Waterlaseservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Waterlaseservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Waterlaseservice@biolase.com | |
| Phone | 1-800-321-6717 |
| Waterlaseservice@biolase.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00647529003800 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161669
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00647529003800]
Moist Heat or Steam Sterilization
[00647529003800]
Moist Heat or Steam Sterilization
[00647529003800]
Moist Heat or Steam Sterilization
[00647529003800]
Moist Heat or Steam Sterilization
[00647529003800]
Moist Heat or Steam Sterilization
[00647529003800]
Moist Heat or Steam Sterilization
[00647529003800]
Moist Heat or Steam Sterilization
[00647529003800]
Moist Heat or Steam Sterilization
[00647529003800]
Moist Heat or Steam Sterilization
[00647529003800]
Moist Heat or Steam Sterilization
[00647529003800]
Moist Heat or Steam Sterilization
[00647529003800]
Moist Heat or Steam Sterilization
[00647529003800]
Moist Heat or Steam Sterilization
[00647529003800]
Moist Heat or Steam Sterilization
[00647529003800]
Moist Heat or Steam Sterilization
[00647529003800]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-20 |
| Device Publish Date | 2023-06-12 |
Devices Manufactured by Biolase, Inc.
| 00647529004722 - Waterlase iPlus Dental Laser System | 2025-02-10 An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser |
| 00647529004777 - Waterlase iPlus Dental Laser System | 2025-02-10 An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser |
| 00647529004647 - Diode Laser Tips | 2024-05-07 An assortment kit composed of thirty single-use fiberoptic laser tip intended for use with Biolase diode laser systems. |
| 00647529003749 - Waterlase Laser Tips | 2023-08-09 A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems. |
| 00647529003770 - Waterlase iPlus Dental Laser System | 2023-08-09 A handpiece utilized with an all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. Th |
| 00647529003787 - Waterlase iPlus Dental Laser System | 2023-08-09 A kit including a handpiece and tips intended to be utilized with an all-tissue dental laser system intended for a variety of so |
| 00647529000120 - Diode Laser Tips | 2023-06-27 A single-use fiberoptic laser tip intended for use with Biolase diode laser systems. |
| 00647529000137 - Diode Laser Tips | 2023-06-27 A single-use fiberoptic laser tip intended for use with Biolase diode laser systems. |
Trademark Results [Waterlase Express]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WATERLASE EXPRESS 87103870 5292447 Live/Registered |
Biolase, Inc. 2016-07-14 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.