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Fda

COHR DIAMOND C-20 DS 0817 1.pdf

COHR DIAMOND C-20 DS 0817 1.pdf

…the manual supplied with the laser.
The Diamond C-20 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 DiamondCx-10LDE Plus DS 0618 1a.pdf

COHR DiamondCx-10LDE Plus DS 0618 1a.pdf

…manual supplied with the laser.
The Diamond Cx-10LDE+ 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 DiamondJ-2 DS 0518 2.pdf

COHR DiamondJ-2 DS 0518 2.pdf

…the manual supplied with the laser.
The Diamond J-2 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 J-3 DS 0617 1.pdf

COHR DIAMOND J-3 DS 0617 1.pdf

…the manual supplied with the laser.
The Diamond J-3 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 J-5 DS 1117 1.pdf

COHR DIAMOND J-5 DS 1117 1.pdf

…the manual supplied with the laser.
The Diamond J-5 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 HighLightFL1000P DS 0617.pdf

COHR HighLightFL1000P DS 0617.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…

Microsoft Word - Coherent Whitepaper - Marking Stainless Steel Medical Devices

Microsoft Word - Coherent Whitepaper - Marking Stainless Steel Medical Devices

…fraud prevention, and distribution regulation. More importantly, medical device marking is becoming increasingly mandatory for the U.S. market under FDA regulations that are being implemented into law. For re-usable, non-implantable devices a critical date is September 24, 2018. After that date, "a…

Flyer FLS A EN 2017.pdf

Flyer FLS A EN 2017.pdf

…Relative humidity max. 80 % 80 % 80 %
Emissions
Heat dissipation approx. 0.4 kW + laser
beam power
0.4 kW + laser
beam power
0.4 kW + laser
beam power
Noise at 1 m, idle 65 dBA 65 dBA 65 dBA
Compliance with standards
CE compliant, FDA compliant

FLS CL EN 2017.pdf

FLS CL EN 2017.pdf

…15 kW
Weight
Laser unit 600 kg
Ambient conditions
Ambient temperature max. 10 - 35 °C
Relative humidity max. 80 %
Emissions
Heat dissipation approx. 0.4 kW + beam power
Noise at 1m, idle 65 dBA
Compliance with standards CE compliant, FDA compliant

COHR DiamondCx-10LDE plus DS 0219 1.pdf

COHR DiamondCx-10LDE plus DS 0219 1.pdf

…manual supplied with the laser.
The Diamond Cx-10LDE+ 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 DiamondJ-5 DS 0119 1.pdf

COHR DiamondJ-5 DS 0119 1.pdf

…the manual supplied with the laser.
The Diamond J-5 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…

Laser Focus World - February 2018

Laser Focus World - February 2018

…prevention, and distribution regulation. More importantly, medical device marking is becoming increasingly mandatory for the U.S. market under new FDA regulations. For reusable, nonimplantable devices, a critical date is September 24, 2018. After that date, "a class II device that is required to be…

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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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