| Primary Device ID | 00855045007114 |
| NIH Device Record Key | eefe8e29-8d48-46b9-b643-3dc787cb80b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Laser Engineering |
| Version Model Number | 125MM Handpiece |
| Catalog Number | SA0220 |
| Company DUNS | 787348452 |
| Company Name | Laser Engineering, 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855045007114 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00855045007114]
Moist Heat or Steam Sterilization
[00855045007114]
Moist Heat or Steam Sterilization
[00855045007114]
Moist Heat or Steam Sterilization
[00855045007114]
Moist Heat or Steam Sterilization
[00855045007114]
Moist Heat or Steam Sterilization
[00855045007114]
Moist Heat or Steam Sterilization
[00855045007114]
Moist Heat or Steam Sterilization
[00855045007114]
Moist Heat or Steam Sterilization
[00855045007114]
Moist Heat or Steam Sterilization
[00855045007114]
Moist Heat or Steam Sterilization
[00855045007114]
Moist Heat or Steam Sterilization
[00855045007114]
Moist Heat or Steam Sterilization
[00855045007114]
Moist Heat or Steam Sterilization
[00855045007114]
Moist Heat or Steam Sterilization
[00855045007114]
Moist Heat or Steam Sterilization
[00855045007114]
Moist Heat or Steam Sterilization
[00855045007114]
Moist Heat or Steam Sterilization
[00855045007114]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-25 |
| Device Publish Date | 2023-10-17 |
| 00855045007510 | Aurora MD30 Laser System |
| 00855045007114 | 125mm Handpiece for CO2 Laser System |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LASER ENGINEERING 73820023 1591884 Dead/Cancelled |
LASER ENGINEERING, INC. 1989-08-17 |