Theralase Inc.

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0607-2020Class IIITLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relSeptember 26, 2019
Z-1266-2020Class IIITLC-2000 Therapeutic Medical Laser SystemSeptember 26, 2019
Z-1348-2020Class IIITLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002September 26, 2019
Z-0606-2020Class IIITLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.September 26, 2019
Z-1326-2020Class IIITLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of kneSeptember 26, 2019
Z-1354-2020Class IIITLC-2000 Therapeutic Medical Laser SystemSeptember 26, 2019
Z-1353-2020Class IIITLC-2000 Therapeutic Medical Laser SystemSeptember 26, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K151816TLC-2000 Therapeutic Medical Laser SystemNovember 19, 2015
K050342THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEMJuly 11, 2005