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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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Diode–pumped solid–state (dpss) surgical laser
Diode–pumped solid–state (dpss) surgical laser
Z12011006
65 devices
Fiber Dust PRO
Quanta System S.p.A.
·
,
Italy
Class IIb
CE/MDD
GUDID
on market
Integre Pro Yellow
Ellex Medical Pty Ltd
·
,
Australia
Class IIb
CE/MDR
GUDID
on market
Integre Pro Green
Ellex Medical Pty Ltd
·
,
Australia
Class IIb
CE/MDR
CE/MDD
+1
authorizations
Q-Switched Nd:YAG laser systems
Shanghai Apolo Medical Technology Co., Ltd
·
,
China
Class IIb
CE/MDD
GUDID
on market
MultiLASE TFL
Quanta System S.p.A.
·
,
Italy
Class IIb
CE/MDD
GUDID
on market
Sphinx Jr.
Lisa Laser Products GmbH
·
,
Germany
Class IIb
CE/MDD
Fiber Dust
Quanta System S.p.A.
·
,
Italy
Class IIb
CE/MDD
GUDID
on market
585
Quanta System S.p.A.
·
,
Italy
Class IIb
CE/MDD
GUDID
on market
ALLY Adaptive Cataract Treatment System
Lensar
·
,
United States
Class IIb
FDA 510(k)
K220259
Active
Cleared 9 Jun 2022
CE/MDR
+1
authorizations
DenaVe
Quanta System S.p.A.
·
,
Italy
Class IIb
CE/MDD
Q-Switched Nd:YAG laser systems
Shanghai Apolo Medical Technology Co., Ltd
·
,
China
Class IIb
FDA 510(k)
×2
K260256
Active
Cleared 4 May 2026
CE/MDD
+1
authorizations
GentleMax Pro Plus Large Spot DCD HP
Candela Corporation
·
,
United States
Class IIb
CE/MDD
GUDID
on market
RevoLix HTL
Lisa Laser Products GmbH
·
,
Germany
Class IIb
CE/MDD
GUDID
on market
PicoWay Laser System
Candela Corporation
·
,
United States
Class IIb
FDA 510(k)
×4
K142372
Active
Cleared 30 Oct 2014
CE/MDD
+1
authorizations
Sphinx Jr.
Lisa Laser Products GmbH
·
,
Germany
Class IIb
CE/MDD
Dornier Thulio
Dornier Medtech GmbH
·
,
Germany
Class IIb
CE/MDR
GUDID
on market
MF 600 Series
Med -Fibers Inc.
·
,
United States
Class IIb
CE/MDD
GUDID
on market
MoXy™
Boston Scientific
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Integre Pro Scan Red-Yellow
Ellex Medical Pty Ltd
·
,
Australia
Class IIb
CE/MDD
GUDID
on market
Pulvis 60+
Quanta System S.p.A.
·
,
Italy
Class IIb
CE/MDD
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