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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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Multi–platform laser
Multi–platform laser
Z12011019
221 devices
Opti-Tip Pack
Lumenis Be Ltd
·
,
Israel
Class IIb
CE/MDR
OPT Handpiece
Lumenis Be Ltd
·
,
Israel
Class IIb
CE/MDR
GUDID
on market
SkyPulse
FOTONA, proizvodnja optoelektronskih naprav d.o.o.
·
,
Slovenia
Class IIb
FDA 510(k)
K193656
Active
Cleared 27 Mar 2020
CE/MDR
+1
authorizations
Duetto Suprema
Quanta System S.p.A.
·
,
Italy
Class IIb
CE/MDD
GUDID
on market
3 x 10 mm cartridge (Optional)
Cynosure Lutronic Technology Corporation
·
,
South Korea
Class IIb
CE/MDR
StarWalker
FOTONA, proizvodnja optoelektronskih naprav d.o.o.
·
,
Slovenia
Class IIb
FDA 510(k)
×2
K202172
Active
Cleared 19 Nov 2020
CE/MDR
+1
authorizations
enlighten Micro Lens Array (MLA)
Cutera, Inc.
·
,
United States
Class IIb
CE/MDR
GUDID
on market
Thunder HR
Quanta System S.p.A.
·
,
Italy
Class IIb
CE/MDD
12 mm, 14 mm, 16 mm cartridge (Optional)
Cynosure Lutronic Technology Corporation
·
,
South Korea
Class IIb
CE/MDR
Galileo
Deka M.E.L.A. SRL
·
,
Italy
Class IIb
CE/MDR
CE/MDD
Q-PLUS Star 1
Quanta System S.p.A.
·
,
Italy
Class IIb
CE/MDD
Platform Treatment Systems
Shanghai Apolo Medical Technology Co., Ltd
·
,
China
Class IIb
FDA 510(k)
K203395
Active
Cleared 28 Jan 2022
CE/MDD
+1
authorizations
SP Spectro
FOTONA, proizvodnja optoelektronskih naprav d.o.o.
·
,
Slovenia
Class IIb
CE/MDR
GUDID
on market
FlexSys
GME German Medical Engineering GmbH
·
,
Germany
Class IIb
FDA 510(k)
K203054
Active
Cleared 5 Mar 2021
CE/MDD
+1
authorizations
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