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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
Kaiser
Ids Ltd.
·
,
South Korea
Class IIb
CE/MDD
Artxel
Ids Ltd.
·
,
South Korea
Class IIb
CE/MDD
SmartXide Punto 50
Deka M.E.L.A. SRL
·
,
Italy
Class IIb
CE/MDR
CE/MDD
Smart Us-20 D
Deka M.E.L.A. SRL
·
,
Italy
Class IIb
CE/MDR
CE/MDD
AcuPulse™
Lumenis Be Ltd
·
,
Israel
Class IIb
CE/MDR
GUDID
on market
N-Pulse FX
Snj Co., Ltd
·
,
South Korea
Class IIb
CE/MDR
Smartxide
Deka M.E.L.A. SRL
·
,
Italy
Class IIb
CE/MDR
Titan
Ids Ltd.
·
,
South Korea
Class IIb
CE/MDD
Di-Rex
Ami Inc.
·
,
South Korea
Class IIb
CE/MDD
Finexel
Snj Co., Ltd
·
,
South Korea
Class IIb
FDA 510(k)
K213557
Active
Cleared 12 Apr 2022
CE/MDD
+1
authorizations
Bluxel
Ids Ltd.
·
,
South Korea
Class IIb
CE/MDD
Monalisa Glide - Glide
Deka M.E.L.A. SRL
·
,
Italy
Class IIb
CE/MDR
Affirm 10mm Tip
Cynosure, LLC
·
,
United States
Class IIb
CE/MDD
GUDID
on market
Angela
Ids Ltd.
·
,
South Korea
Class IIb
CE/MDD
Affirm 14mm Tip
Cynosure, LLC
·
,
United States
Class IIb
CE/MDD
GUDID
on market
SmartXide
Deka M.E.L.A. SRL
·
,
Italy
Class IIb
CE/MDR
Hemera
Deka M.E.L.A. SRL
·
,
Italy
Class IIb
CE/MDR
Smartxide2 C80
Deka M.E.L.A. SRL
·
,
Italy
Class IIb
CE/MDD
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