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Fda

COHR HighLightFL Standard DS 1119.pdf

COHR HighLightFL Standard DS 1119.pdf

…designed 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…

COHR HighLightFL Compact DS 1119.pdf

COHR HighLightFL Compact DS 1119.pdf

…designed 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…

COHR HighLightFL-ARM Standard DS 1119.pdf

COHR HighLightFL-ARM Standard DS 1119.pdf

…designed 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…

COHR HighLightFL ARM Compact DS 1119.pdf

COHR HighLightFL ARM Compact DS 1119.pdf

…designed 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…

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…

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…