Theralase Inc.
Theralase Inc. appears in FDA public data with 7 recalls, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1354-2020, Class III) was initiated on September 26, 2019. Its most recent 510(k) clearance was granted on November 19, 2015.
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 2
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1354-2020 | Class III | TLC-2000 Therapeutic Medical Laser System | September 26, 2019 |
| Z-0607-2020 | Class III | TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary rel | September 26, 2019 |
| Z-1266-2020 | Class III | TLC-2000 Therapeutic Medical Laser System | September 26, 2019 |
| Z-0606-2020 | Class III | TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain. | September 26, 2019 |
| Z-1326-2020 | Class III | TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of kne | September 26, 2019 |
| Z-1348-2020 | Class III | TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002 | September 26, 2019 |
| Z-1353-2020 | Class III | TLC-2000 Therapeutic Medical Laser System | September 26, 2019 |