LUMENIS VersaPulse PowerSuite - 1.4 Certification of Compliance; 1.5 Service Information & FDA Compliance

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1.4 CERTIFICATION OF COMPLIANCE
The VersaPulse PowerSuite laser is designed and tested in accordance with Lumenis’s procedures for self
certification for a CE mark.
The CE mark is a certification label which allows Lumenis to sell the VersaPulse PowerSuite Lasers
throughout the European community. This label certifies that the VersaPulse PowerSuite laser meets all
regulations set forth by various countries in Europe. It is important to ensure that this label is on the laser
chassis.
1.5 SERVICE INFORMATION & FDA COMPLIANCE
In compliance to the FDA, brochures and specifications sheets must include a reproduction of a complete
warning logotype or Class IIa warning statement as required on the product (1040.10(h)(2)(i)). Servicing
information must contain the following (1040.10(h)(2)(ii)):
• Procedures for service with appropriate warnings to avoid exposure. (Refer to Section 3)
• A schedule of maintenance to maintain the product in compliance (Refer to Section 3)
• A list of controls that could increase the level of accessible radiation.
•• The energy UP/DN buttons on the LCD touch screen display.
•• The power UP/DN buttons on the LCD touch screen display.
•• The energy UP/DN buttons on the remote control display.
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