Solta Medical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3011423170	3004106598	Solta Medical, Inc.	1	N	2026-01-01	11720 N Creek Pkwy N Suite 100 Bothell WA US 98011

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
180433	2006667781	K242142	Fraxel® FTX Laser System	GEX	2024-08-21
180433	1724306553	K223647	CLEAR+BRILLIANT TOUCH® Laser System	GEX	2022-12-29
180433	1783887787	K190555	PowerX Lipo System	QPB	2019-05-01
180433	1079172197	K190551	VASERlipo System	QPB	2019-05-01
180433	1279927540	K170758	Thermage FLX System and Accessories	GEI	2017-09-22
180433	1299120161	K141063	LINSCAN 808, LINSCAN 980	GEX	2014-07-15
180433	1314159705	K132431	THERMAGE CPT SYSTEM	GEI	2013-09-06
180433	1788582346	K130193	FRAXEL DUAL 1550/1927 LASER SYSTEM	GEX	2013-06-14
180433	1826818315	K121515	ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM	ONF	2012-06-05
180433	1425399644	K120433	CLEAR + BRILLIANT LASER SYSTEM	ONG	2012-04-02
180433	1788349622	K120328	ORIGINS LIPOHARVESTING SYSTEM	MUU	2012-09-17
180433	1709282010	K113255	PUREGRAFT 850/PURE SYSTEM	MUU	2012-03-07
180433	1146413831	K112626	LIPSONIX(R) SYSTEM MODEL 2	OHV	2011-10-20
180433	1833459545	K110349	CLEAR+BRILLIANT LASER SYSTEM	ONG	2011-05-03
180433	1699116282	K110306	SOUND SURGICAL VASER 2.1 LIPO SYSTEM	QPB	2011-06-23
180433	1921456565	K110255	SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM	QPB	2011-04-04
180433	1959857667	K101490	FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US	ONG	2010-09-08
180433	2031309128	K100874	LIPOSONIX SYSTEM, MODEL 1 P00XXXX	OHV	2011-08-19
180433	1022225986	K092923	CYTORI PUREGRAFT 250/PURE SYSTEM	MUU	2010-01-06
180433	1482892669	K091420	FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500	ONG	2009-10-14
180433	1828482690	K090580	THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES	GEI	2009-06-26
180433	1520983921	K083730	ISOLAZ	GEX	2009-01-09
180433	1759847132	K080915	FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES	GEX	2008-07-01
180433	1978146889	K071051	FRAXEL III SR LASER SYSTEM AND ACCESSORIES	GEX	2007-11-02
180433	1030999200	K070284	FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM)	GEX	2007-05-17
180433	1886943569	K063038	FRAXEL III SR LASER SYSTEM AND ACCESSORIES	GEX	2007-04-27
180433	2045038344	K033942	THERMAGE THERMACOOL SYSTEM	GEI	2004-02-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GEX	9	2024-08-21
QPB	4	2019-05-01
GEI	4	2017-09-22
ONG	4	2012-04-02
MUU	3	2012-09-17
OHV	2	2011-10-20
ONF	1	2012-06-05

PMN#

CLEAR+BRILLIANT TOUCH® Laser System
2022-12-29
Solta Medical, Inc.
THERMAGE CPT SYSTEM
2013-09-06
SOLTA MEDICAL, INC.
FRAXEL DUAL 1550/1927 LASER SYSTEM
2013-06-14
SOLTA MEDICAL, INC.
ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM
2012-06-05
SOLTA MEDICAL, INC.
CLEAR + BRILLIANT LASER SYSTEM
2012-04-02
SOLTA MEDICAL, INC.
CLEAR+BRILLIANT LASER SYSTEM
2011-05-03
SOLTA MEDICAL, INC.
FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500
2009-10-14
SOLTA MEDICAL, INC.
THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES
2009-06-26
SOLTA MEDICAL, INC.