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Powerx Footswitch

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 120-0053Model VaserLipoRef 115-0031Ref 110-0039

by Solta Medical, Inc.

Identity

Trade Name
POWERX FOOTSWITCH EUDAMED
POWERX EUDAMEDFDA UDI
VASER FDA UDI
Generic Name
Ultrasonic surgical system generator FDA UDI
Foot-switch, electrical FDA UDI
Liposuction system FDA UDI
Device Name
VENTX FOOTSWITCH EUDAMED
Mendieta Kit for PowerX® EUDAMED
PowerX System, 220V EUDAMED
ACCESSORYKIT, MENDIETA, POWERX FDA UDI
FOOTSWITCH, POWERX, GEM, ORANGE FDA UDI
POWERX, 220V FDA UDI
Model / Reference
VaserLipo EUDAMED
120-0053 EUDAMEDFDA UDI
115-0031 EUDAMEDFDA UDI
110-0039 EUDAMEDFDA UDI
Description
ACCESSORYKIT, MENDIETA, POWERX FDA UDI
FOOTSWITCH, POWERX, GEM, ORANGE FDA UDI
POWERX, 220V FDA UDI

Identifiers

Catalog Number
115-0031 FDA UDI
120-0053 FDA UDI
110-0039 FDA UDI
Primary DI / UDI-DI
00816995027430 EUDAMEDFDA UDI
00816995021605 EUDAMEDFDA UDI
00850608002544 EUDAMEDFDA UDI
Basic UDI-DI
081699502B0012W9 EUDAMED
B-00816995021605 EUDAMED
B-00850608002544 EUDAMED
FDA Product Code
QPB FDA UDI
MUU FDA UDI
EMDN Code
L0399 GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
L250399 LIPOSUCTION INSTRUMENTS, REUSABLE - OTHER EUDAMED
Z12010880 INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES EUDAMED
Z12040214 LIPOSUCTION SYSTEMS EUDAMED
GMDN Term
Ultrasonic surgical system generator FDA UDI
Foot-switch, electrical FDA UDI
Liposuction system FDA UDI

Classification

Device Class
Class I EUDAMED
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
878.5040 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDIFDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDIFDA UDI

Serial Number

No

FDA UDIFDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Powerx Footswitch by Solta Medical, Inc. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Solta Medical, Inc.
EUDAMED SRN
US-MF-000018343
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (7)

  • EUDAMED c6b7b8f9-669b-4dab-ad2c-98c244fa38a8 61 fields · synced Jul 27, 2026
  • FDA UDI f7e5068f-3abe-4193-9300-782083365adb 34 fields · synced May 30, 2026
  • FDA UDI 9d89d9cb-b655-4977-8c9c-7e2dac370e6b 34 fields · synced May 30, 2026
  • FDA UDI 1e707d41-1641-4a69-a96f-d6324e62fc43 34 fields · synced May 30, 2026
  • EUDAMED 0d5dabcf-4d2f-4bb1-90e2-1dbcabcd2309 61 fields · synced Jul 15, 2026
  • EUDAMED 260d20fb-2eef-422d-882e-f8cde889dde4 61 fields · synced Jul 17, 2026
  • EUDAMED 6e2ad560-8bdb-4124-a2fc-f778d8da39e9 61 fields · synced Jul 27, 2026