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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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Ophthalmology instruments
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Therapeutic and surgical ophtholmological treatments instruments
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Laser photocoagulators
Laser photocoagulators
Z12120202
13 devices
Devices
Ophthalmic Green Laser System – 532nm
Appasamy Associates Private Limited
·
,
IN
Class IIb
CE/MDR
Multicolor Laser Photocoagulator MC-500
Nidek Co., Ltd.
·
,
JP
Class IIb
CE/MDR
4202074CE02
Active
Valid to Mar 2028
GUDID
on market
Spirit Trio
Active Optical Systems Ltd
·
,
IL
Class I
CE/MDR
Navilas Laser System 577s
OD-OS GmbH
·
,
DE
Class IIb
FDA 510(k)
K141851
Active
Cleared 2 Jan 2015
FDA 510(k)
K162191
Active
Cleared 22 Nov 2016
+3
authorizations
cFactor
Active Optical Systems Ltd
·
,
IL
Class IIa
CE/MDD
GUDID
on market
Prime 810
Top Engineering Sarl
·
,
CH
Class I
CE/MDR
Navilas Laser System 577SL
OD-OS GmbH
·
,
DE
Class IIb
FDA 510(k)
K251772
Active
Cleared 29 Oct 2025
CE/MDR
PurePoint
Alcon Laboratories, Inc.
·
,
US
Class IIb
CE/MDR
GUDID
on market
Green Laser Photocoagulator GYC-500
Nidek Co., Ltd.
·
,
JP
Class IIb
CE/MDR
4202074CE02
Active
Valid to Mar 2028
FDA 510(k)
K152603
Active
Cleared 2 May 2016
+1
authorizations
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