2. INTENDED USE
SkinPen®Precision is a microneedling device to improve the appearance of
fine lines, wrinkles, and scars on the face and body. Rx Only.
3. CONTRAINDICATIONS
The use of SkinPen®Precision should not be used on patients with active skin
cancer or active bacterial, fungal or viral (i.e. herpes, warts) skin infections in
the treatment area(s).
4. WARNINGS
SkinPen®Precision has not been evaluated in the following patient populations,
and as such, precautions should be taken when determining whether to treat
patients with a history of the following conditions: Eczema, psoriasis, and other
chronic conditions in the treatment area; herpes simplex infections; keloid
scars; patients on anticoagulants; scars and stretch marks less than one year
old; scleroderma; and wound-healing deficiencies.
5. PRECAUTIONS
Universal precautions are necessary during microneedling. Microneedling
should not be used within the orbital rim, such as the eyelids. Special care
needs to be exercised on patients with the following conditions or on the
following medications: Actinic (solar) keratosis; active acne; allergies to
stainless steel; collagen vascular diseases or cardiac abnormalities; diabetes;
eczema, psoriasis and other chronic conditions on other areas of the body;
immunosuppressive therapy; irritated skin in the treatment area; history
of contact dermatitis; hemorrhagic disorder or hemostatic dysfunction;
isotretinoin drugs, pregnancy or nursing; open wounds or sores; irritated
skin; raised moles in the treatment area; and rosacea.
6. ELECTRICAL SAFETY WARNINGS
• No modification of this equipment is allowed.
Only use included SkinPen®Precision adapter and charger base.
• Do not plug product into outlet with a voltage other than
specified on the charger. (90-264Vac).
• Never force plug into an outlet –
if it does not easily fit into the outlet, discontinue use.
• Discontinue use if product appears damaged in any way.
• Do not use or charge if cord or plug is damaged.
• Keep cord away from heated surfaces.
• Do not store the pen and/or charger base near a
sink or where it can fall or be pulled into water.
• 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
SkinPen®Precision Rev.V1.0 4
