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Solta Medical, Inc.

United States·US-MF-000018343

Last updated September 17, 2026

What Solta Medical, Inc. makes

Solta Medical, Inc. manufactures liposuction systems and cannulas, ultrasonic surgical system generators, multi-modality skin surface treatment systems, dermatological laser beam guiding handpieces, radio-frequency skin contouring system applicator tips, ultrasonic skin/body contouring systems, and electrical foot-switches.

The company's portfolio includes devices classified as Class I, Class II, Class IIa, and Class IIb, and is listed in both eudamed and fda_udi registries. Solta Medical is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Solta Medical, Inc. manufacture?

Where is Solta Medical, Inc. based?

Solta Medical, Inc. is based in the United States, as indicated by the country information provided in the device data.

Which regulatory registries list Solta Medical's devices?

Solta Medical's devices are listed in both the eudamed and fda_udi registries, as specified in the device data provided.

How are Solta Medical's devices classified?

Solta Medical's devices are classified as Class I, Class II, Class IIa, and Class IIb, with the most common categories being liposuction system cannula, reusable, liposuction system, and ultrasonic surgical system generator.

AI-generated from registry data and not verified by a human reviewer.

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 (413)

Page 6 of 9

Device	Model / Reference	Registries	Class	Status
Origins	130-0101	FDA UDI	Class II	Active
Vaser	110-0022R	FDA UDI	Class II	Active
Vaser	130-0093	FDA UDI	Class II	Active
Origins	810-SGBU4525SWFT	FDA UDI	Class II	Active
Vaser	130-0152	FDA UDI	Class II	Active
Origins	810-TPBT3525LLNR	FDA UDI	Class II	Active
Vaser	130-0115	FDA UDI	Class II	Active
Origins	810-YFBU3025VXNR	FDA UDI	Class II	Active
Vaser	130-0558	FDA UDI	Class II	Active
Isolaz	IS2-TIP-PFKIT-12	FDA UDI	Class II	Active
Vaser	P010339-02	FDA UDI	Class II	Active
Vaser	130-0111	FDA UDI	Class II	Active
Fraxel FTX	MCSYSFTX-R	FDA UDI	Class II	Active
Fraxel	MC-SYS-ACC-RP	FDA UDI	Class II	Active
Liposonix	P006530-04	FDA UDI	Class II	Active
Vaser	110-0037R	FDA UDI	Class II	Active
Vaser	130-0117	EUDAMEDFDA UDI	Class II	Active
Fraxel FTX	MCSYSFTX	FDA UDI	Class II	Active
Vaser	130-0524	EUDAMEDFDA UDI	Class II	Active
Origins	810-BKBU4025LLNR	FDA UDI	Class II	Active
Origins	810TSSP4030PXNR	FDA UDI	Class II	Active
Clear & Brilliant	CB-HP-1440	FDA UDI	Class II	Active
Fraxel	MC-F2-RT1ES	FDA UDI	Class II	Active
Vaser	130-0096	EUDAMEDFDA UDI	Class II	Active
Origins	810-FRBU3525LSNR	FDA UDI	Class II	Active
Origins	810-VXBU3026LLNR	FDA UDI	Class II	Active
Isolaz	IS2-CART-110	FDA UDI	Class II	Active
Origins	810-CNBU4030PXNR	FDA UDI	Class II	Active
Thermage	TTNS3.00E2-900	FDA UDI	Class I	Active
Origins	810-BKBU4040LSNR	FDA UDI	Class II	Active
Origins	810-SLBT4026PXNR	FDA UDI	Class II	Active
Isolaz	IS-TC-4ZE	FDA UDI	Class II	Active
Origins	820-BMBU1509LLNR	FDA UDI	Class II	Active
Origins	810-GHBU3735VXNR	FDA UDI	Class II	Active
Vaser	130-0574	EUDAMEDFDA UDI	Class II	Active
Thermage	TTNS3.00C3-400	FDA UDI	Class I	Active
Origins	810-TPBT3025LLNR	FDA UDI	Class II	Active
Isolaz	40-01746	FDA UDI	Class II	Active
Fraxel	MC-SYS-ACC-RS/RF	FDA UDI	Class II	Active
Vaser	130-0110	FDA UDI	Class II	Unknown
Origins	820-EMBU4025LLNR	FDA UDI	Class II	Active
Vaser	110-0035R	FDA UDI	Class II	Active
Origins	810-YMBU4030SWNR	FDA UDI	Class II	Active
Vaser	130-0562	EUDAMEDFDA UDI	Class II	Active
Origins	810-VXBU4626VXNR	FDA UDI	Class II	Active
Vaser	130-0526	EUDAMEDFDA UDI	Class II	Active
Origins	830-HDFNCNTR	FDA UDI	Class II	Active
Vaser	130-0551	EUDAMEDFDA UDI	Class II	Active
Vaser	130-0120	FDA UDI	Class II	Active
Clear+brilliant	CBT-CONSOLE	FDA 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.

Solta Medical, Inc. has 6 recall records initiated between 2010-12-15 and 2023-02-16, with statuses recorded as open, classified, and terminated. The reasons given include obsolete versions of the Laser Treatment Settings card containing incorrect indications, a service unit potentially improperly tested and calibrated, potential for inadvertent laser firing, potential inaccurate calibration by service depot repair, and complaints of sparking of electrosurgical device tips.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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.