Tabla De Contenido; Corporate Information; Regulatory Compliance - Capillus Ultra Manual De Instrucciones

TABLE OF CONTENTS
Figures ................................................................................................................ 1
Important Safety Instructions ............................................................................... 3
Corporate Information .......................................................................................... 4
Regulatory Compliance ........................................................................................ 4
About the Capillus Device .................................................................................. 5
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• Introduction
• Indications for Use
• Is Capillus Laser Therapy Right for You?
•
Intended Usage
•
Frequency of Use
•
Duration of Use
What's Included .................................................................................................. 5
Instructions for Charging Battery Pack ................................................................. 6
Instructions for Use ............................................................................................. 6
Safety Labels ....................................................................................................... 6
Contraindications ................................................................................................. 7
Maintenance Instructions .................................................................................... 7
Operating Information .......................................................................................... 7
Storage & Transport Information .......................................................................... 8
Warranty .............................................................................................................. 8
Electromagnetic Interference - EMC/EMF ............................................................. 8
Troubleshooting .................................................................................................. 9
Capillus Device Specifications ............................................................................ 9
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CORPORATE INFORMATION

Curallux, LLC
1715 NW 82 Ave., Miami, FL 33126
Toll-Free USA: 1 (888) 272-9599
Phone: +1 (786) 888-6249
Email: [email protected]
Website: www.capillus.com
Capillus and the Capillus logo are trademarks of Curallux, LLC registered in the USA and other
countries. Patent number US10099065 B2. Capillus laser devices are made in the USA from foreign-
sourced raw materials. All product information and articles are intended to be for informational
purposes only.

REGULATORY COMPLIANCE

Curallux, LLC lasers comply with 21 CFR 1040 for Class 3R Laser Products as administered by the
Center for Device and Radiological Health of the US Food and Drug Administration and standard
IEC60825 of the International Electrotechnical Commission.
Capillus's Quality System for medical device design and manufacturing is registered by Intertek and
is compliant with the following:
ISO13485:2016
Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding
Part 1.6)
Brazil: Federal Law n. 6360/76; RDC ANVISA n. 16/2013; RDC ANVISA n. 23/2012; RDC ANVISA n.
67/2009; RDC ANVISA n. 56/2001
Canada: Medical Devices Regulations - Part 1 - SOR 98/282
United States: 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 (Subparts A to D)
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