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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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Laser surgery instruments - other
Laser surgery instruments - other
Z12011099
339 devices
Waterlase Laser Tips - Quartz
Biolase Mg LLC
·
,
United States
Class IIa
CE/MDD
C1 Cap / C5 Tip
Lutronic Corporation
·
,
South Korea
Class IIb
CE/MDR
GUDID
on market
Waterlase Laser Tips - Sapphire
Biolase Mg LLC
·
,
United States
Class IIa
CE/MDD
Selecta DuetTM
Lumenis Be, Inc.
·
,
United States
Class IIb
CE/MDR
GUDID
on market
İnvamed
İnvamed Sağlik İlaç Sanayi̇ Ve Ti̇caret A.Ş.
·
,
Türkiye
Class IIa
CE/MDD
İnvamed
İnvamed Sağlik İlaç Sanayi̇ Ve Ti̇caret A.Ş.
·
,
Türkiye
Class IIa
CE/MDD
Waterlase Laser Tips - Sapphire
Biolase Mg LLC
·
,
United States
Class IIa
CE/MDD
Digital DuetTM
Lumenis Be, Inc.
·
,
United States
Class IIb
CE/MDR
GUDID
on market
Laser Handpiece
Biolase Mg LLC
·
,
United States
Class I
CE/MDD
GUDID
on market
Bare Fiber
CeramOptec GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
Waterlase Laser Tips - Quartz
Biolase Mg LLC
·
,
United States
Class IIa
CE/MDD
Bare Fiber
CeramOptec GmbH
·
,
Germany
Class IIa
CE/MDR
Smart532 TM
Lumenis Be, Inc.
·
,
United States
Class IIb
CE/MDR
GUDID
on market
Waterlase Laser Tips - Quartz
Biolase Mg LLC
·
,
United States
Class IIa
CE/MDD
HiScan SCAR 3
Deka M.E.L.A. SRL
·
,
Italy
Class IIb
CE/MDR
GUDID
on market
Diode Laser Tips - Pre Initiated Tips
Biolase Mg LLC
·
,
United States
Class IIa
CE/MDD
İnvamed
İnvamed Sağlik İlaç Sanayi̇ Ve Ti̇caret A.Ş.
·
,
Türkiye
Class IIa
CE/MDD
Picosecond Nd:YAG Laser Systems
Shanghai Apolo Medical Technology Co., Ltd
·
,
China
Class IIb
FDA 510(k)
K200116
Active
Cleared 28 May 2020
CE/MDD
+1
authorizations
Laser Handpiece
Biolase Mg LLC
·
,
United States
Class I
CE/MDD
Diode Laser Tips - Pre Initiated Tips
Biolase Mg LLC
·
,
United States
Class IIa
CE/MDD
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