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Fda

COHR HighLight DL-HP DS 0918.pdf

COHR HighLight DL-HP DS 0918.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 0818.pdf

COHR HighLightFL Compact SingleMode 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…

COHR DIAMOND Cx-10 DS 0118 1.pdf

COHR DIAMOND Cx-10 DS 0118 1.pdf

…manual supplied with the laser.
The Diamond Cx-10 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…

StarCut Tube Laser Cutting Machine | High-Precision Laser Tube Cutting System

StarCut Tube Laser Cutting Machine | High-Precision Laser Tube Cutting System

…removal even during the cutting process
* Fiber and/or femto laser can be integrated into StarCut Tube
* Sorter module adaptable
* IQ / OQ for FDA documentation according to GMP The StarCut Tube systems are 4-axes CNC laser cutting solutions for fully-automated cutting of tube and flat material,…

Life Sciences and Medical Applications

Life Sciences and Medical Applications

…system. Because laser vision correction is not a medical necessity, it is considered cosmetic surgery and as such it is closely supervised by the FDA and other regulatory agencies around the world. These regulatory bodies require the highest standards in product quality and safety. All Coherent…

EU Medical USP 0618.pdf

EU Medical USP 0618.pdf

03.2018 www.medizin-und-technik.de EVK 11,50 Ingenieurwissen für die Medizintechnik TITELTHEMA 3D-Druck in der Medizin FDA Guidance, Erfahrungen und Perspektiven Seite 20 Roboterchirurgie Deutsche Hersteller haben bisher die Entwicklung verschlafen Seite 16 Auslandsmarkt Thailand Nur langfristiges…

COHR HighLight DL-HQ DS 0918.pdf

COHR HighLight DL-HQ DS 0918.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 DC Series DS 0619web.pdf

COHR DC Series 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 HighLight DD DS 0819.pdf

COHR HighLight DD DS 0819.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 HighLightDL HPS DS 0819.pdf

COHR HighLightDL HPS DS 0819.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…

Diamond J-3-5 Series OEM Lasers Preinstallation Manual, Rev. AA

Diamond J-3-5 Series OEM Lasers Preinstallation Manual, Rev. AA

…before the
product is shipped. The form of this report is covered in a pamphlet
entitled: Compliance Guide for Lasers, HHS Publication
FDA 86-8260. This pamphlet is available at no cost from:
U.S. Food and Drug Administration
Center for Devices and Radiological Health

00 E-250 Pre.book

00 E-250 Pre.book

…before the
product is shipped. The form of this report is covered in a pamphlet
entitled: Compliance Guide for Lasers, HHS Publication FDA
86-8260. This pamphlet is available at no cost from:
U.S. Food and Drug Association
Center for Devices and Radiological Health