Recall Z-1681-2020— Solta Medical Inc

Name: FDA recall Z-1681-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-30

Class II · Terminated

Class II FDA medical device recall by Solta Medical Inc, initiated 2019-12-30, terminated 2024-04-29. It names one FDA 510(k) clearance: K132431. Product: Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.. Reason: Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribute to potential skin burns..

Recalling firm: Solta Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2019-12-30
Terminated: 2024-04-29
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K132431 — THERMAGE CPT SYSTEMSolta Medical, Inc.·cleared 2013-09-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Reason for recall

Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribute to potential skin burns.

Data sourced from openFDA. This site is unofficial and independent of the FDA.