| Primary Device ID | 00627987397499 |
| NIH Device Record Key | 2f69df4d-ceca-4ff3-a78d-535779c414e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Theralase |
| Version Model Number | TLC-1000 |
| Company DUNS | 258595334 |
| Company Name | Theralase Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | 00627987397499 [Primary] |
| NHN | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-22 |
| Device Publish Date | 2023-12-14 |
| 00627987397475 | Cool Laser Therapy System |
| 00627987397499 | Therapeutic Laser System |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THERALASE 97343587 not registered Live/Pending |
Theralase Technologies Inc. 2022-04-01 |
![]() THERALASE 75688455 2629654 Live/Registered |
THERALASE, INC. 1999-04-22 |
![]() THERALASE 74727104 not registered Dead/Abandoned |
Laser BioTherapy, Inc. 1995-09-11 |