Solta Medical Inc recalls thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc.…

Recall date

February 16, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1354-2023

FDA classification

Class II

Brand / firm

Solta Medical Inc

Sold / distributed

U.S. Distribution to state of: MD

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.