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Products without an intended medical purpose (annex XVI)
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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
/
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
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
X0599
15 devices
Devices
V Tip electrode
Classys
·
,
KR
Class IIb
CE/MDR
I Tip electrode
CLASSYS Inc.
·
,
KR
Class IIb
CE/MDR
Sculpture Stone Electrode
Indiba S.A.U.
·
,
ES
Class I
CE/MDR
Grounding Plate
Classys
·
,
KR
Class IIb
CE/MDR
GUDID
on market
Volnewmer
CLASSYS Inc.
·
,
KR
Class IIb
FDA 510(k)
K240248
Active
Cleared 29 Apr 2024
CE/MDR
Sculpture Tip Electrode
Indiba S.A.U.
·
,
ES
Class I
CE/MDR
Sculpture Cherry Electrode
Indiba S.A.U.
·
,
ES
Class I
CE/MDR
Sculpture Shell Electrode
Indiba S.A.U.
·
,
ES
Class I
CE/MDR
Sculpture Roll Electrode
Indiba S.A.U.
·
,
ES
Class I
CE/MDR
Sculpture Gua Sha Electrode
Indiba S.A.U.
·
,
ES
Class I
CE/MDR
Sculpture Disc Electrode
Indiba S.A.U.
·
,
ES
Class I
CE/MDR
Sculpture Q-Roll Electrode
Indiba S.A.U.
·
,
ES
Class I
CE/MDR
Xen
Australian Aesthetic Devices
·
,
AU
Class IIa
CE/MDR
F Tip electrode
CLASSYS Inc.
·
,
KR
Class IIb
CE/MDR
Sculpture Wave Electrode
Indiba S.A.U.
·
,
ES
Class I
CE/MDR
RESISTIVE ELECTRODE Ø30 mm
Indiba S.A.U.
·
,
ES
Class I
CE/MDR
Fascia Flex
Indiba S.A.U.
·
,
ES
Class I
CE/MDR
Resistive electrode 35mm ø
Indiba S.A.U.
·
,
ES
Class I
CE/MDR
Resistive electrode 90 mm ø
Indiba S.A.U.
·
,
ES
Class I
CE/MDR
CAPACITIVE CURVED ELECTRODE 12 mm
Indiba S.A.U.
·
,
ES
Class I
CE/MDR
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