| Primary Device ID | 00860011139706 |
| NIH Device Record Key | d4a69dc3-df52-4434-a293-860b0433fe7f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Laser Engineering |
| Version Model Number | OTO Handpiece |
| Catalog Number | 1059746 |
| Company DUNS | 028541358 |
| Company Name | LASER ENGINEERING |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 5085202552 |
| r.rudko@laserengineering.com | |
| Phone | 5085202552 |
| r.rudko@laserengineering.com | |
| Phone | 5085202552 |
| r.rudko@laserengineering.com | |
| Phone | 5085202552 |
| r.rudko@laserengineering.com | |
| Phone | 5085202552 |
| r.rudko@laserengineering.com | |
| Phone | 5085202552 |
| r.rudko@laserengineering.com | |
| Phone | 5085202552 |
| r.rudko@laserengineering.com | |
| Phone | 5085202552 |
| r.rudko@laserengineering.com | |
| Phone | 5085202552 |
| r.rudko@laserengineering.com | |
| Phone | 5085202552 |
| r.rudko@laserengineering.com | |
| Phone | 5085202552 |
| r.rudko@laserengineering.com | |
| Phone | 5085202552 |
| r.rudko@laserengineering.com | |
| Phone | 5085202552 |
| r.rudko@laserengineering.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860011139706 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00860011139706]
Moist Heat or Steam Sterilization
[00860011139706]
Moist Heat or Steam Sterilization
[00860011139706]
Moist Heat or Steam Sterilization
[00860011139706]
Moist Heat or Steam Sterilization
[00860011139706]
Moist Heat or Steam Sterilization
[00860011139706]
Moist Heat or Steam Sterilization
[00860011139706]
Moist Heat or Steam Sterilization
[00860011139706]
Moist Heat or Steam Sterilization
[00860011139706]
Moist Heat or Steam Sterilization
[00860011139706]
Moist Heat or Steam Sterilization
[00860011139706]
Moist Heat or Steam Sterilization
[00860011139706]
Moist Heat or Steam Sterilization
[00860011139706]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-19 |
| Device Publish Date | 2024-04-11 |
| 00860011139706 | Re-usable fiberoptic handpiece for lasers |
| 10866988000299 | This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to t |
| 00866988000285 | This device is an internally coated fusee silica waveguide used to deliver CO2 laser energy to t |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LASER ENGINEERING 73820023 1591884 Dead/Cancelled |
LASER ENGINEERING, INC. 1989-08-17 |