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Volnewmer

EUDAMEDFDA 510(k)

Class IIb (EU MDR)

Ref VLMM00003510(k) K240248

by Classys

Identity

Trade Name
VOLNEWMER EUDAMED
Device Name
RADIOSURGICAL UNITS EUDAMED
Model / Reference
VLMM00003 EUDAMED

Identifiers

Primary DI / UDI-DI
08800016902747 EUDAMED
Basic UDI-DI
8800016902693YC EUDAMED
510(k) Number
K240248 FDA 510(k)
FDA Product Code
GEI FDA 510(k)
EMDN Code
X0599 HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER EUDAMED

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Market of Registration
Spain EUDAMED
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

Volnewmer by Classys — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Classys
EUDAMED SRN
KR-MF-000010116
Authorised Representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Sources (2)

  • EUDAMED f10dfcce-4a07-487e-9b73-fa3468dc7b88 61 fields · synced Jul 9, 2026
  • FDA 510(k) K240248 24 fields · synced May 18, 2026