Dornier MedTech Laser GmbH

Address:ARGELSRIEDER FELD 7,WESSLING Bavaria,DE

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Powered Laser Surgical Instrument (GEX) (10)

Premarket Exempt

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Dornier MedTech - 04049958000065 Catalog Number : K1001295

Device Description : 10 Units of 600 Micron Disposable ND YAG Laser Lightguide with Rinsing Tube, 3. 10 Units of 600 Micron Disposable ND YAG Laser Lightguide with Rinsing Tube, 3.5 meter length, 1.8 mm outer diameter

Device Class : 2

Duns Number: 389567538

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 04049958000171 Catalog Number : K2011500

Device Description : Medilas Fibertome 8100 ND YAG Laser

Device Class : 2

Duns Number: 389567538

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Dornier MedTech - 04049958000218 Catalog Number : K2011627

Device Description : Medilas D LiteBeam+ Diode Laser, D-Plug

Device Class : 2

Duns Number: 389567538

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Dornier MedTech - 04049958000225 Catalog Number : K2011691

Device Description : Medilas D MultiBeam Diode Laser, D-Plug

Device Class : 2

Duns Number: 389567538

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Dornier MedTech - 04049958001307 Catalog Number : K2011743

Device Description : Medilas D FlexiPulse Diode Laser, D-Plug

Device Class : 2

Duns Number: 389567538

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Dornier MedTech - 04049958001383 Catalog Number : K2011915

Device Description : Medilas D MultiBeam Diode Laser, Green Pilot Beam, D-Plug

Device Class : 2

Duns Number: 389567538

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Dornier MedTech - 04049958001468 Catalog Number : K1008084

Device Description : 600 Micron Disposable Diode Laser Lightguide, 3.5 meter length, 1.07 mm outer diameter

Device Class : 2

Duns Number: 389567538

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 04049958001529 Catalog Number : K1001291

Device Description : 600 Micron Disposable ND YAG Nozzle Tip Laser Lightguide, 3.5 meter length, 2.1 600 Micron Disposable ND YAG Nozzle Tip Laser Lightguide, 3.5 meter length, 2.1 mm outer diameter

Device Class : 2

Duns Number: 389567538

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 04049958001536 Catalog Number : K1001292

Device Description : 600 Micron Disposable ND YAG Nozzle Tip Laser Lightguide, 3.5 meter length, 1.8 600 Micron Disposable ND YAG Nozzle Tip Laser Lightguide, 3.5 meter length, 1.8 mm outer diameter

Device Class : 2

Duns Number: 389567538

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Dornier MedTech - 04049958001543 Catalog Number : K1001293

Device Description : 600 Micron Disposable ND YAG Threaded Nozzle Tip Laser Lightguide, 3.5 meter len 600 Micron Disposable ND YAG Threaded Nozzle Tip Laser Lightguide, 3.5 meter length, 2.2 mm outer diameter

Device Class : 2

Duns Number: 389567538

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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