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Solta Medical, Inc.

USA · Bothell

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

8listed device types

Class I 1Class II 7Class III 0

plus 25 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class II 1Class III 1

23 including historic records

TWTaiwanTFDA

12valid device licences

Class II 12

SGSingaporeHSA SMDR

7device registrations

CLASS B 1CLASS C 6

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

21active ARTG entries

Class I 8IIa 4IIb 9

HKHong KongMDACS

4valid listings

Class III 4

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

12active registrations

Class 2a 7Class 2b 5

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States25 registration records, 13 510(k), 0 PMA

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: Solta Medical, Inc. · SOLTA MEDICAL INC. · SOLTA MEDICAL, INC.

FDA 510(k) clearances by year

22009

12011

22012

22013

12017

12018

22019

12022

12024

FDA listed device types

Massager, Therapeutic, Electric 1Electrosurgical, Cutting & Coagulation & Accessories 1Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1System, Suction, Lipoplasty 1System, Suction, Lipoplasty For Removal 1Powered Laser Surgical Instrument With MicrobeamFractional Output 1Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption 1Powered Laser Surgical Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242142	Fraxel® FTX Laser System	2024-08-21
US	K223647	CLEAR+BRILLIANT TOUCH® Laser System	2022-12-29
US	K190555	PowerX Lipo System	2019-05-01
CA	68634	FRAXEL SR LASER SYSTEM	Class III
CA	86608	CLARO IPL ACNE CLEARING DEVICE	Class II