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Fda

COHR HighLightDL HPR DS 0818.pdf

COHR HighLightDL HPR DS 0818.pdf

…in strict accordance
with the respective safety regulations. We certify that each laser
manufactured by our company complies with FDA Radiation
Performance Standards, 21 CFR Subchapter J and with IEC 60825.
Warning labels as shown in the figure appear on each Coherent-Rofin…

CohrRofi Whitepaper - Marking Stainless Steel Medical Devices de.pdf

CohrRofi Whitepaper - Marking Stainless Steel Medical Devices de.pdf

…Vermeidung von Rückgabebetrug und verbesserte Distributionssteuerung. Wichtiger noch, auf dem amerikanischen Markt wird im Zuge der Umsetzung der FDA Richtlinien die Markierung medizintechnischer Produkte zunehmend Pflicht. Für wiederverwendbare, nicht-implantierbare Artikel ist der 24. September…

Flyer KLS 2017.pdf

Flyer KLS 2017.pdf

…Cooling power max. 8.5 kW, depending on laser output
Weight
Laser unit 200 kg
Ambient conditions
Ambient temperature max. 10 - 35 °C
Relative humidity max. 80 %
Emissions
Noise at 1m, idle 60 dBA
Compliance with standards
CE compliant, FDA compliant

Flyer NA 2017 en.pdf

Flyer NA 2017 en.pdf

…1500 kg
Ambient conditions
Ambient temperature 10-35 °C (stabilized ± 2°C)
Relative humidity max. 80 %
Emissions
Heat dissipation max. 0.4 kW + laser beam power
Noise at 1 m, idle 65 dBA
Compliance with standards
CE compliant, FDA compliant
NA N

COHR DIAMOND C 30 C 30 DS 0619 3.pdf

COHR DIAMOND C 30 C 30 DS 0619 3.pdf

…supplied with the laser.
The Diamond C-30 & C-30+ CO2
laser is a component that does not include all safety features as required by the FDA and the Center for Devices and Radiological Health (CDRH). It is sold solely to qualified manufacturers
who in their end product will supply…

COHR DIAMOND C 55 C 60 DS 0619 2.pdf

COHR DIAMOND C 55 C 60 DS 0619 2.pdf

…supplied with the laser.
The Diamond C-55 and C-60+ CO2
laser is a component that does not include all safety features as required by the FDA and the Center for Devices and Radiological Health (CDRH). It is sold solely to qualified manufacturers who in their end product will supply all…

COHR DIAMOND E-1000 DS 1118 1.pdf

COHR DIAMOND E-1000 DS 1118 1.pdf

…manual supplied with the laser.
The DIAMOND E-1000/E-1000i CO2 laser is a component that does not include all safety features as required by the FDA and the Center for Devices and Radiological Health (CDRH). It is sold solely to qualified manufacturers who in their end product will supply all…

COHR HighLightFL Compact MultiMode DS 0619web.pdf

COHR HighLightFL Compact MultiMode DS 0619web.pdf

…in strict accordance
with the respective safety regulations. We certify that each laser
manufactured by our company complies with FDA Radiation
Performance Standards, 21 CFR Subchapter J and with IEC 60825.
Warning labels as shown in the figure appear on each Coherent-Rofin…

COHR HighLightFL Compact SingleMode DS 0619web.pdf

COHR HighLightFL Compact SingleMode DS 0619web.pdf

…in strict accordance
with the respective safety regulations. We certify that each laser
manufactured by our company complies with FDA Radiation
Performance Standards, 21 CFR Subchapter J and with IEC 60825.
Warning labels as shown in the figure appear on each Coherent-Rofin…

COHR HighLightFL Standard FFC DS 0619web.pdf

COHR HighLightFL Standard FFC DS 0619web.pdf

…in strict accordance
with the respective safety regulations. We certify that each laser
manufactured by our company complies with FDA Radiation
Performance Standards, 21 CFR Subchapter J and with IEC 60825.
Warning labels as shown in the figure appear on each Coherent-Rofin…

COHR HighLightFL Standard FFS DS 0619web.pdf

COHR HighLightFL Standard FFS DS 0619web.pdf

…in strict accordance
with the respective safety regulations. We certify that each laser
manufactured by our company complies with FDA Radiation
Performance Standards, 21 CFR Subchapter J and with IEC 60825.
Warning labels as shown in the figure appear on each Coherent-Rofin…

COHR DIAMOND J-3-5 COlaser DS 0617 2.pdf

COHR DIAMOND J-3-5 COlaser DS 0617 2.pdf

…in the manual supplied with the laser.
The Diamond J-3-5 CO laser is a component that does not include all safety features as required by the FDA and the Center for Devices and Radiological Health (CDRH). It is sold solely to qualified manufacturers who in
their end product will supply all…

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Risk factors: Except for the historical information contained here, many of the matters discussed in this Web site are forward-looking statements, based on expectations at the time they were made, that involve risks and uncertainties that could cause our results to differ materially from those expressed or implied by such statements. These risks are detailed in the “Factors That May Affect Future Results” section of our latest 10-K or 10-Q filing. Coherent assumes no obligation to update these forward-looking statements.


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