| 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 |