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TRUSCULPT OPERATOR MANUAL
D1395, REV. K, 02/18
Regulatory Compliance
Classifications and Compliance
The truSculpt system is a Class II medical device as defined by the US Code of Federal Regulations and
a Class IIb device as defined by the European Communities Medical Device Directive.
The truSculpt complies with the following standards:
• US FDA 21 CFR 878.4400 (2015)
• European Communities Medical Devices Directive 93/42/EEC
• IEC 60601-1 (Edition 3.0, 2005 + CORR. 1:2006 + CORR. 2:2007); IEC 60601-1-2 (Edition
3, 2007); IEC 60601-1-4 (Edition 1.1, 1996+A1:1999); IEC 60601-1-6 (Edition 3.1, 2013);
and IEC 60601-2-2 (Edition 5.0, 2009)
EMC IEC 60601-1-2:2001 Class A Compliance Statement
The truSculpt system is suitable for use in all establishments other than domestic and those directly
connected to the public low-voltage power supply network that supplies buildings used for domestic
purposes.
System Labels
As required by national and international regulatory agencies, appropriate regulatory compliance labels
have been mounted in specified locations. All operators should be familiar with the location and meaning
of these labels. Refer to Appendix A for a description of all symbols on the system labels.
(01)00816722021403
(11)YYMMDD
(21)TSyyyyy
Unique Device Identifier (UDI) Label
2D barcode
Global Trade Identification
Number (GTIN)
Date of Manufacture
Serial Number
Rear Panel Label