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Medical equipment and related accessories, software and consumables
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Instruments for functional explorations and therapeutic interventions
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General and multidisciplinary surgery instruments
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Laser surgery instruments
/
Carbon dioxide surgical laser
Carbon dioxide surgical laser
Z12011005
73 devices
Surgical CO2 Laser(RF Type)
Lutronic Corporation
·
,
South Korea
Class IIb
CE/MDD
Smartxide Hs
Deka M.E.L.A. SRL
·
,
Italy
Class IIb
CE/MDR
CE/MDD
SmartXide Punto 30
Deka M.E.L.A. SRL
·
,
Italy
Class IIb
CE/MDD
Ecoxel
Ids Ltd.
·
,
South Korea
Class IIb
CE/MDD
Med-870+
Beijing Kes Biology Technology Co., Ltd.
·
,
China
Class IIb
CE/MDD
MedArt 620 FRx Intenz
MedArt ApS
·
,
Denmark
Class IIb
CE/MDD
UNILAS Touch
Limmer Laser GmbH
·
,
Germany
Class IIb
CE/MDD
Ga-2000011GR
Lumenis (Germany) GmbH
·
,
Germany
Class IIb
CE/MDR
SmartXide PRO
Deka M.E.L.A. SRL
·
,
Italy
Class IIb
CE/MDR
CO2 Laser Therapy Systems
Shanghai Apolo Medical Technology Co., Ltd
·
,
China
Class IIb
CE/MDD
GUDID
on market
Silklase Infinity
INTERmedic Arfran s.a.
·
,
Spain
Class IIb
CE/MDR
Bioxel
Ami Inc.
·
,
South Korea
Class IIb
CE/MDD
GUDID
on market
CO2 Laser Therapy Systems
Shanghai Apolo Medical Technology Co., Ltd
·
,
China
Class IIb
FDA 510(k)
K201109
Active
Cleared 15 Jul 2020
CE/MDD
+1
authorizations
Dermaxel
Ami Inc.
·
,
South Korea
Class IIb
CE/MDD
Prismxel
Ids Ltd.
·
,
South Korea
Class IIb
CE/MDD
UltraPulse® α
Lumenis Be Ltd
·
,
Israel
Class IIb
CE/MDR
GUDID
on market
Odyssey
Ids Ltd.
·
,
South Korea
Class IIb
CE/MDD
UltraPulse® α
Lumenis Be Ltd
·
,
Israel
Class IIb
CE/MDR
GUDID
on market
DX300
Ami Inc.
·
,
South Korea
Class IIb
CE/MDD
Ultra pulse CO2 fractional laser
Daeju Meditech Engineering Co., Ltd
·
,
South Korea
Class IIb
CE/MDD
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