ClearanceBrief
Company ยท CA

Theralase Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2015. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)

Product codes

CodeDeviceRecords
NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy9

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Nov 19, 2015K151816TLC-2000 Therapeutic Medical Laser System
Theralase, Inc., CA
NHN
Jul 11, 2005K050342THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM
Theralase, Inc., CA
NHN

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 13, 2020Theralase Inc.
TLC-2000 Therapeutic Medical Laser System
Terminated
NHNK151816
Feb 13, 2020Theralase Inc.
TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain.
Terminated
NHNK151816
Feb 13, 2020Theralase Inc.
TLC-2000 Therapeutic Medical Laser System
Terminated
NHNK151816
Feb 13, 2020Theralase Inc.
TLC-2000 Therapeutic Medical Laser System Power Pack, Model Number TLC-2002
Terminated
NHNK151816
Dec 5, 2019Theralase Inc.
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
Terminated
NHNK151816
Dec 5, 2019Theralase Inc.
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
Terminated
NHNK151816
Sep 26, 2019Theralase Inc.
TLC-2000 Therapeutic Medical Laser System
Terminated
NHNK151816
Get alerts for these product codes