Page 68 Ulthera, Inc
11. Safety Standards and Regulatory
Classifications
FDA Product Classification 878.4590
UL60601-1, IEC60601-1 Medical Electrical Equipment, Part 1: General Requirements for
Safety.
Class I dev ice, type B applied part, non AP/APG rated.
Ingress protection: IPx0 (“Ordinary Equipment”) for Control Unit; IPx1 for mated
transducer and handpiece.
Mode of operation: Continuous.
IEC60601-1-2, Electromagnetic Compatibility. CISPR 11 class A, Group 1.
IEC60601-2-37, Particular requirements for the safety of ultrasonic medical diagnostic
and monitoring equipment
Patient contacting materials comply with ISO 10993-1
NRTL Certification: Canadian Standards Association (CSA)
ISO 13485 Quality Assurance Standard
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