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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 (405)

Page 2 of 9

Device	Model / Reference	Registries	Class	Status
Thermage	TG-2B	FDA UDI	Class I	Active
Vaser	130-0112	FDA UDI	Class II	Unknown
Vaser	130-0168	FDA UDI	Class II	Active
Fraxel	MC-RS-CA	FDA UDI	Class II	Active
Origins	830-HDASLULK	FDA UDI	Class II	Active
Vaser	130-0578	FDA UDI	Class II	Active
Origins	810-BKBU4025SWNR	FDA UDI	Class II	Active
Isolaz	40-01363	FDA UDI	Class II	Active
Origins	820-MHBU2030LLNR	FDA UDI	Class II	Active
Origins	820-CMBT1509LLNR	EUDAMEDFDA UDI	Class II	Active
Vaser	130-0113	FDA UDI	Class II	Active
Origins	810-YFBU2523PXNR	FDA UDI	Class II	Active
Origins	810-TPBU4030VXNR	FDA UDI	Class II	Active
Isolaz	IS2-TIP-AC-M-1	FDA UDI	Class II	Active
Powerx	XHPR	FDA UDI	Class II	Active
Vaser	110-0036R	FDA UDI	Class II	Active
Origins	130-0105	FDA UDI	Class II	Active
Isolaz	IS2-TIP-AC-S-1	FDA UDI	Class II	Active
Origins	810-MCBU5030VXNR	FDA UDI	Class II	Active
Fraxel	MC-F2-INTL-RT1ES	FDA UDI	Class II	Active
Origins	810-TPBU3030VXNR	FDA UDI	Class II	Active
Thermage	TF-3-30	FDA UDI	Class II	Active
Thermage	TTNS3.00C3-900	FDA UDI	Class I	Active
Origins	810-TPBU3040VXNR	FDA UDI	Class II	Active
Origins	810MBBU3030PXNR	FDA UDI	Class II	Active
Origins	810-TPSP4025PXNR	FDA UDI	Class II	Active
Vaser	130-0016	EUDAMEDFDA UDI	Class II	Active
Origins	810-TABU3026PXNR	FDA UDI	Class II	Active
Isolaz	40-01367	FDA UDI	Class II	Active
Origins	810MCBT5032PXNR	FDA UDI	Class II	Active
Origins	810-BKBU4625VXNR	FDA UDI	Class II	Active
Vaser	P007721	FDA UDI	Class II	Active
Origins	810-CNBU5030PXNR	FDA UDI	Class II	Active
Isolaz	IS2-TIP-AC-L-4	FDA UDI	Class II	Active
Origins	810-VXBU4634VXCX	FDA UDI	Class II	Active
Origins	830-HDASVXPL	EUDAMEDFDA UDI	Class II	Active
Vaser	130-0560	EUDAMEDFDA UDI	Class II	Active
Origins	810MCBU4626VXNR	FDA UDI	Class II	Active
Origins	820-FNBU2030LLNR	FDA UDI	Class II	Active
Isolaz	IS2-CONSOLE	FDA UDI	Class II	Active
Origins	810-GHBU3026VXNR	FDA UDI	Class II	Active
Origins	810-VXBU2417LLNR	FDA UDI	Class II	Active
Vaser	115-0021	FDA UDI	Class II	Active
Origins	810-VGBU4025SWNR	FDA UDI	Class II	Active
Origins	820-FNBU3023LLNR	FDA UDI	Class II	Active
Vaser	130-0116	EUDAMEDFDA UDI	Class II	Active
Origins	130-0064	FDA UDI	Class II	Active
Origins	810-YMBU4030VXNR	FDA UDI	Class II	Active
Origins	810-TPBT6030SWNR	FDA UDI	Class II	Active
Vaser	115-0011	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.

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.