Certificates and safety
The producer aims to provide a product that fully meets customer expectations and demands. Safety and quality are ensured through the use of restrictive Quality Management System, including the commitment to comply with regulatory requirements and to maintain environmental standards.
Safety of ViviComb laser has been confirmed by ISO and IEC quality certificates, GMP standards and CE Declaration of Conformity:
- ISO 13485:2003
- ISO 9001:2008
- IEC 60825-1:2007 - 03 ED2.0
- USFDA Good Manufacturing Practice (GMP) - in accordance with 21 CFR 820, FDA Quality System Regulations
- CE Declaration of Conformity
ISO compliance certificate guarantees that Quality Management System is applied in accordance with International Organization for Standardization. Regular inspections are carried out in order to maintain certification and ensure commitment to quality.
In order to use ViviComb safely, please read and follow the below precautions:
- Do not look directly at the laser light or its reflection in the mirror, because it can temporarily irritate eyes. In addition, when using ViviComb it is forbidden to use a magnifying glass.
- Keep out of reach of children.
- Do not use ViviComb laser comb near water. Dropping the device into the water can result in an electric shock.
- If the device cable is damaged, do not power on the device. It can result in an electric shock.
- Do not use ViviComb laser near hot surfaces, as it may result in device malfunction and an electric shock in consequence.
- If you are taking medications or are using products causing photosensitivity, make sure that ViviComb laser does not cause any reaction on your skin. To do so, turn on the device and apply the laser to your forearm for 2 minutes. If there is no redness, rash or any other allergic reaction 5 minutes after applying the laser light, you can safely use ViviComb. Otherwise, please contact us to send us the product back and receive a refund of money.
- Do not use acetone or other solvents to clean ViviComb's laser comb - they can block the laser light.
- If ViviComb has malfunctioned, do not attempt to repair it yourself. Use the device for its intended use only, as described above.
WARNING: Keep away from water. Contact of the device with water can cause an electric shock.