Recall Z-1354-2023— Solta Medical Inc

Name: FDA recall Z-1354-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-16

Class II · Ongoing

Class II FDA medical device recall by Solta Medical Inc, initiated 2023-02-16. It names one FDA 510(k) clearance: K173759. Product: thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general surgical procedures for electrocoagulation and hemostasis; " Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; " Non-invasive treatment of wrinkles and rhytids. The Thermage CPT System ( System ) consists of the RF Generator/ Cooling System, 16.00 cm2 Handpiece ( Body Handpiece ), Standard Handpiece with Vibration ( Face Handpiece ), optional electric Footswitch, accessory cables, Return Pad, Return Pad Cable, and Treatment Tips.. Reason: A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station..

Recalling firm: Solta Medical Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-02-16
Firm location: Bothell, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K173759 — Thermage CPT System and AccessoriesSolta Medical·cleared 2018-01-08

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 THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general surgical procedures for electrocoagulation and hemostasis; " Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; " Non-invasive treatment of wrinkles and rhytids. The Thermage CPT System ( System ) consists of the RF Generator/ Cooling System, 16.00 cm2 Handpiece ( Body Handpiece ), Standard Handpiece with Vibration ( Face Handpiece ), optional electric Footswitch, accessory cables, Return Pad, Return Pad Cable, and Treatment Tips.

Reason for recall

A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.

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