SkinPen
®
Precision Rev.V1.0
Declaration of Conformity
Bellus Medical, LLC. Declares that the SkinPen
®
Precision and
SkinPen
®
Precision charger base complies with the following
normative documents:
IEC 62133, IEC 60601-1, IEC60601-1-2, IEC 60601-1, IEC 62366,
ISO 14971:2012, IEC 62304, ISO:13485:2003, MDD 93/42/EEC, RoHS,
ISO15223:2012, IEC 60601-1-6, IEC 60529, IEC 62304, ISO 10993-1,
ISTA-2A, IEC 62133, UN 38.3
This device complies with Part 15 of the FCC Rules. Operation is subject
to the following two conditions: (1) this device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
12001 North Central Expressway
Suite 250
Dallas, TX 75243
1.888.372.3982
www.skinpen.com
www.bellusmedical.com
SkinPen
®
Precision Rev.V1.0