919 results
·
54ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Solta Medical, Inc.
FDA registration
Solta Medical, Inc.·8 products·🇺🇸 United States
THERMAGE
FDA Adverse Event
Malfunction
·SOLTA MEDICAL, INC·Product code GEI·November 29, 2011
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.
FDA Enforcement
Class II
·Ongoing·Solta Medical Inc·April 19, 2023
ISOLAZ LIGHT THERAPY AESTHERA COMPANY SOLTA MEDICAL INC. LAZER TREATMENT
FDA Adverse Event
Injury
·SOLARA/AESTHERA /ISOLAZ NUD INC·Product code GEX·April 10, 2012
FRAXEL
FDA Adverse Event
Other
·SOLTA MEDICAL, INC.·Product code GEI·October 3, 2012
THERMAGE NXT
FDA Adverse Event
Injury
·SOLTA MEDICAL·Product code GEI·January 13, 2011
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.
FDA Recall
Open, Classified
·Solta Medical Inc·Product code GEI·February 16, 2023
Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA The Fraxel re:store Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
FDA Recall
Terminated
·Solta Medical, Inc.·Product code ONG·December 15, 2010
THERMAGE CPT SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC.·Product code GEI·January 23, 2020
ISOLAZ PRO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC.·Product code GEI·May 8, 2012
VASERLIPO SYSTEM AND ACCESSORIES
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·September 18, 2024
VASERLIPO SYSTEM AND ACCESSORIES
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code QPB·June 7, 2023
CLEAR + BRILLIANT LASER SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code ONG·February 17, 2022
THERMAGE CPT SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC.·Product code GEI·November 18, 2016
THERMAGE TIP
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC.·Product code GEI·October 13, 2016
FRAXEL DUAL
FDA Adverse Event
Injury
·SOLTA MEDICAL INC·Product code ONG·February 2, 2012
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL INC.·Product code OHV·April 14, 2014
LIPOSONIX SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL INC.·Product code OHV·May 8, 2014
VASERLIPO SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL INC.·Product code OHV·May 13, 2014
FRAXEL RESTORE LASER
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code GEX·May 4, 2010