| Primary Device ID | 00647529002315 |
| NIH Device Record Key | e827c209-d647-4de2-87f4-b504bf13ed93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Waterlase Express Handpiece |
| Version Model Number | 7220001 |
| Catalog Number | 7220001 |
| 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 | 00647529002315 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
[00647529002315]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-23 |
| 00647529002315 | A reusable handpiece intended for use with the Waterlase Express Laser System in a variety of de |
| 00647529003480 | A reusable handpiece intended for use with the Waterlase Express Laser System in a variety of de |
| 00647529001509 | A reusable handpiece intended for use with the Waterlase Express Laser System in a variety of de |