FDA Registration
Active
🇨🇦 Canada
TLC-2000 Therapeutic Medical Laser System
Reg #: 3003614490
·
FEI: 3003614490
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Theralase Technologies Inc.
- Registration Number
- 3003614490
- FEI Number
- 3003614490
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 41 Hollinger Road
- City
- Toronto Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K151816
Owner / Operator
- Firm Name
- THERALASE INC.
- Operator Number
- 9052867
- Address
- 41 Hollinger Road
- City
- Toronto
- State
- Ontario
- Postal Code
- M4B 3G4
- Country
- CA
- Correspondent
- Roger - Dumoulin-White
US Agent
- Business Name
- Theralase Biotech Inc.
- Contact Name
- Roger DuMoulin-White
- Address
- 1220 North Market Street, Suite 808
- City
- Wilmington
- State
- DE
- ZIP
- 19801
- Country
- US
- [email protected]
- Phone
- 302 4215752 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | NHN | Class 2 | Physical Medicine | No | 2017-05-01 |
Proprietary Names
TLC-2000 Therapeutic Medical Laser System
Establishment Types
Manufacture Medical Device