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1 - 12 of 73 Products for 'Fda' Page 1 of 7 |
Related Categories: Cx 10 | Cx 10l | Cx-10l | Cx-10l 10.6 | Diamond Cx-10

Fda

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…

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 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…

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…

PL-501 Book.book

PL-501 Book.book

…Manual
1-8
IMPORTANT!
The PL-501 laser device by itself does NOT comply with the following:
--US FDA CFR 21 requirements for certified laser products
--US FDA CFR 21, section 1040.10 and 1040.11
--IEC 60825-1:2014
The laser can only be used as an OEM component of a…

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 With CNC-driven rotary-, x-, y- and z-axes and a solid granite machine set-up, even taper-free or offset cuts are…

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…

AppNote Japanese Black Marking.pdf

AppNote Japanese Black Marking.pdf

APPLICATION HIGHLIGHTS © 2019 Coherent, Inc. | www.coherent.com | 10.2019 UDIUnique Device Identifier FDA 2025 MDR: Medical Device Regulation PowerLine Rapid NX P E E K / P P S U PowerLine Rapid NX 1.4301 (JIS: SUS304) sales.tokyo@coherent.com PowerLine Rapid NX 21.4301 (JIS: 304))

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…