Device Description; Intended Use - Bellus Medical SkinPen Precision Manuel D'utilisation

1. DEVICE DESCRIPTION

The SkinPen Precision device consists of a microneedling pen handpiece,
®
and a sterile needle cartridge. The accessories are a charging base and a
BioSheath. Each component and accessory will be explained to understand
how SkinPen Precision works.
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D
C
B
A
G
SkinPen Precision Components
®
A SkinPen Precision Handpiece - Part #10130010 / REF 100
A Power Indicator Light
B Power On/Off Button
C Charge Level Indicator
D Microneedling Connector
E Ergonomic Handle Grip
F Base Charger AC/DC Adapter - Part #10130012
G Inductive Charging Base - Part #10130011 / REF 101
2 PN#16130015 | Rev. C | International
SKINPEN
Fig 1.
E
F

2. INTENDED USE

SkinPen Microneedling System and SkinPen+Skinfuse Treatment kit are a
system that utilizes Collagen Induction Therapy to treat Melasma, acne and
surgical scars.
PRECISION TREATMENT KIT
®
INCLUDES:
SkinPen Precision Cartridge
Part #10230010 / REF 014
EO (Ethylene Oxide) Sterilized, disposable needle cartridge
packaged and labeled individually. Proprietary needle
cartridge. *Cartridges are not to be resterilzed or reused.
SkinPen Precision BioSheath
Part #10130001
The SkinPen Precision and needle cartridge interface
®
with a nonsterile and disposable BioSheath to prevent
contamination of the SkinPen Precision
LIFT HG
Part #11720001
Lift HG is a hydrogel wound dressing (without drugs and/
or biologics) to protect against abrasion and friction during
the microneedling procedure. It may be applied additionally
the day of the procedure to prevent the skin from drying
out post procedure
RESCUE
Part #11420001
Cosmetic calming complex applied liberally AM/PM, as
needed to soothe and calm skin. Suggested to be used 24
hours post treatment.
PN#16130015 | Rev. C | International
.
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