| Primary Device ID | 00647529003718 |
| NIH Device Record Key | 4bb23725-de4b-4d09-9725-cf9955296c45 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Waterlase Laser System Gold Straight Handpiece |
| Version Model Number | 7220003 |
| Catalog Number | 7220003 |
| Company DUNS | 152165700 |
| Company Name | BIOLASE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00647529003718 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
[00647529003718]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-07 |
| Device Publish Date | 2018-08-07 |
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| 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. |
| 00647529000687 - Waterlase Laser Tips | 2023-06-27 A single-use fiberoptic accessory intended for use with Waterlase Laser delivery systems. |
| 00647529000922 - Waterlase Laser Tips | 2023-06-27 A single-use fiberoptic accessory intended for use with Waterlase Laser delivery systems. |
| 00647529001509 - Waterlase Express Handpiece | 2023-06-27 A reusable handpiece intended for use with the Waterlase Express Laser System in a variety of dental hard-tissue and soft-tissue |