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Solta Medical, Inc.

United States·US-MF-000018343

Last updated September 17, 2026

Information

Country: United States
Address: 11720 North Creek Parkway N. Suite 100, Bothell, United States
Website: solta.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Sophie Xu
EUDAMED SRN: US-MF-000018343
FDA FEI Number: 3004106598
DUNS Number: —

Catalogue (405)

Page 1 of 9

Device	Model / Reference	Registries	Class	Status
"Skin Ports and Accessories"	115-0003	EUDAMED	Class IIb	Active
Origins	810-STBU4015VXNR	EUDAMED	Class IIa	Active
L250399	115-0005	EUDAMED	Class IIb	Active
Powerx	115-0018-D	FDA UDI	Class II	Active
Isolaz	40-01230	FDA UDI	Class II	Active
Thermage	TW-1	FDA UDI	Class I	Active
Vaser	130-0118	EUDAMEDFDA UDI	Class II	Active
Clear+brilliant	CBT-KEY-12	FDA UDI	Class II	Active
Thermage	TG-2BR-UPG	FDA UDI	Class I	Active
Clear+brilliant	CBT-HP-1440	FDA UDI	Class II	Active
Fraxel	MC-RE:PAIR-NO-SPATULA	FDA UDI	Class II	Active
Origins	810-MBBT4030PXNR	FDA UDI	Class II	Active
Origins	810-MDMD5030PXNR	FDA UDI	Class II	Active
Origins	130-0106	FDA UDI	Class II	Active
Origins	820-BMBT2020LLNR	FDA UDI	Class II	Active
Vaser	130-0127	EUDAMEDFDA UDI	Class II	Active
Vaser	115-0019-D	FDA UDI	Class II	Active
Vaser	P007008-01	FDA UDI	Class II	Active
Origins	820-BMBT3015LLNR	FDA UDI	Class II	Active
Origins	820-FNBU3015LLNR	FDA UDI	Class II	Active
Vaser	115-0004	EUDAMEDFDA UDI	Class II	Active
Powerx	115-0018	FDA UDI	Class II	Active
Vaser	130-0019	EUDAMEDFDA UDI	Class II	Active
Origins	820-BMBT1509LLCX	FDA UDI	Class II	Active
Fraxel	MC-TIP-RE:PAIR-4L	FDA UDI	Class II	Active
Origins	810-TPBU3023VXNR	FDA UDI	Class II	Active
Thermage Flx	TF-3	FDA UDI	Class I	Active
Powerx	XHP	FDA UDI	Class II	Active
Isolaz	IS2-TIP-AC-L-1	FDA UDI	Class II	Active
Vaser	115-0029	FDA UDI	Class II	Active
Origins	820-FNBU3025LLNR	FDA UDI	Class II	Active
Vaser	130-0153	EUDAMEDFDA UDI	Class II	Active
Fraxel	MC-TIP-RE:PAIR-KIT	FDA UDI	Class II	Active
Clear+brilliant	CBT-HP-1927-R	FDA UDI	Class II	Active
Origins	810-MBBT5030VXNR	FDA UDI	Class II	Active
Vaser	130-0094	FDA UDI	Class II	Active
Origins	820-BMBT1307LLNR	FDA UDI	Class II	Active
Isolaz	40-01862	FDA UDI	Class II	Active
Origins	810-TPBU3025VXNR	FDA UDI	Class II	Active
Fraxel	MC-RS-SOC-ACC	FDA UDI	Class II	Active
Fraxel FTX	MC15MM12	FDA UDI	Class II	Active
Origins	810-MCBU4030PXNR	FDA UDI	Class II	Active
Origins	810-VDVD3024VXNR	FDA UDI	Class II	Active
Origins	820-EFBU2023LLNR	FDA UDI	Class II	Active
Origins	810-TSSP3025VXNR	FDA UDI	Class II	Active
Origins	810-GHBU3717VXNR	FDA UDI	Class II	Active
Origins	810-TPBT4030SWNR	FDA UDI	Class II	Active
Vaser	115-0043	EUDAMEDFDA UDI	Class II	Active
Origins	130-0103	FDA UDI	Class II	Active
Vaser	115-0038	EUDAMEDFDA UDI	Class II	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 16, 2023	Z-1354-2023	—	open, classified	A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
Dec 30, 2019	Z-1681-2020	—	terminated	Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribute to potential skin burns.
Jun 1, 2017	Z-3048-2017	—	terminated	Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.
Jun 1, 2017	Z-3047-2017	—	terminated	Potential inaccurate calibration by service depot repair, which could contribute to patients being burnt by the device. This only impacts units serviced between the dates of 09/08/2016 and 05/23/2017.
Mar 20, 2014	Z-1463-2014	—	terminated	Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma.
Dec 15, 2010	Z-1010-2011	—	terminated	The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs.