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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
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Carbon dioxide surgical laser
Carbon dioxide surgical laser
Z12011005
73 devices
Devices
Multisys
Ids Ltd.
·
,
KR
Class IIb
CE/MDD
SmartXide HS
Deka M.E.L.A. SRL
·
,
IT
Class IIb
CE/MDD
CE/MDR
Microsys
Ids Ltd.
·
,
KR
Class IIb
CE/MDD
SmartXide Touch C40
Deka M.E.L.A. SRL
·
,
IT
Class IIb
CE/MDD
CE/MDR
Ac-0013552
Lumenis Be Ltd
·
,
IL
Class IIb
CE/MDR
Rex-Co
Ami Inc.
·
,
KR
Class IIb
CE/MDD
Smaxel Premium
Ids Ltd.
·
,
KR
Class IIb
CE/MDD
SmartXide Tetra PRO
Deka M.E.L.A. SRL
·
,
IT
Class IIb
CE/MDR
Smartxide Touch C60
Deka M.E.L.A. SRL
·
,
IT
Class IIb
CE/MDR
CE/MDD
Fractional CO2 Laser Machine
Zhengzhou PZ Laser Slim Technology Co., Ltd.
·
,
CN
Class IIb
FDA 510(k)
K250782
Active
Cleared 12 Jun 2025
CE/MDR
Smartxide Touch - Surgico
Deka M.E.L.A. SRL
·
,
IT
Class IIb
CE/MDR
Fractional CO2 Laser Machine
Zhengzhou PZ Laser Slim Technology Co., Ltd.
·
,
CN
Class IIb
CE/MDR
BX300
Ami Inc.
·
,
KR
Class IIb
CE/MDD
Globalipl
Beijing Globalipl Development Co., Ltd.
·
,
CN
Class IIb
CE/MDR
CE/MDD
+1
authorizations
Neoxel
Ami Inc.
·
,
KR
Class IIb
CE/MDD
Silklase
INTERmedic Arfran s.a.
·
,
ES
Class IIb
CE/MDR
SmartXide 50 HS
Deka M.E.L.A. SRL
·
,
IT
Class IIb
CE/MDR
SmartXide Junior
Deka M.E.L.A. SRL
·
,
IT
Class IIb
CE/MDD
CE/MDR
Laser Station
Lasering s.r.l.
·
,
IT
Class IIb
CE/MDR
Smaxel
Ids Ltd.
·
,
KR
Class IIb
CE/MDD
GUDID
on market
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