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Solta Medical Inc

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
13
Inspections
7
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1354-2023Class IIthermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B ***February 16, 2023
Z-1681-2020Class IIThermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)0December 30, 2019
Z-3047-2017Class IIVASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifieJune 1, 2017
Z-3048-2017Class IIVASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA The VaserJune 1, 2017
Z-1463-2014Class IIFRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedureMarch 20, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K242142Fraxel® FTX Laser SystemAugust 21, 2024
K223647CLEAR+BRILLIANT TOUCH® Laser SystemDecember 29, 2022
K190555PowerX Lipo SystemMay 1, 2019
K190551VASERlipo SystemMay 1, 2019
K173759Thermage CPT System and AccessoriesJanuary 8, 2018
K170758Thermage FLX System and AccessoriesSeptember 22, 2017
K132431THERMAGE CPT SYSTEMSeptember 6, 2013
K130193FRAXEL DUAL 1550/1927 LASER SYSTEMJune 14, 2013
K121515ISOLAZ 2 INTENSE PULSED LIGHT SYSTEMJune 5, 2012
K120433CLEAR + BRILLIANT LASER SYSTEMApril 2, 2012
K110349CLEAR+BRILLIANT LASER SYSTEMMay 3, 2011
K091420FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500October 14, 2009
K090580THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIESJune 26, 2009