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Cutera Excel V - Treatment Guidelines and Safety; Guidelines and Indications for Use; Contraindications and Warnings; Important Safety Precautions

Cutera Excel V
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D1091 Rev.M August. 2016
3
USING THESE TREATMENT GUIDELINES
These treatment guidelines are based on physician feedback and
are provided as a guide only. They are not designed to be a
substitute for clinical training. The excel V should only be operated
by qualified practitioners who have received appropriate training
and have thoroughly reviewed the Operator Manual that shipped
with the system. When using the laser, always observe laser-
tissue interaction and clinical endpoints to determine appropriate
settings.
The parameter recommendations in these guidelines are for
patients with Fitzpatrick skin types I-VI with the 1064 nm
wavelength and skin types I-IV (unless otherwise indicated) with
the 532 nm wavelength. In general, longer pulse durations and
lower fluence are recommended for darker skin types and tanned
skin. The increased melanin content in darker skin increases the
risk for side effects.
Test pulses are always advised. Start conservatively, fire a test
pulse, and evaluate tissue response before continuing or adjusting
parameters. Be advised, however, that potential adverse reactions
may take 24-48 hours or longer to appear.
INDICATIONS FOR USE
Refer to the Operator Manual for a complete list of indications for use.
The Cutera excel V is cleared for the treatment of:
Benign vascular lesions
Benign pigmented lesions
Benign cutaneous lesions
Wrinkles
Mild to moderate inflammatory acne
Hair reduction
CONTRAINDICATIONS
Pregnant patients
Patients undergoing treatment for skin cancer
WARNINGS
Do not treat over dysplastic nevi or questionable pigmented lesions.
o Online Melanoma resources include www.aad.org and www.cancer.org.
Do not treat over or close to:
o tattoos or permanent make-up
o metal or electronic implants
Hair removal by lasers or intense pulse light sources can cause increased hair growth in some individuals.
Based upon currently available data, the highest risk groups for this response are females of Mediterranean,
Middle Eastern and South Asian heritage treated on the face and neck
PRECAUTIONS
Do not treat patients who have taken Accutane in the past 6 months.
Anticoagulants may increase the risk of purpura or bruising.
Gold therapy may cause blue-gray discoloration.
Vitiligo may cause de-pigmentation.
Pre-treatment with an antiviral may be indicated for patients with herpes.
Use caution when treating patients with a history of keloids or hypertrophic scarring.
Do not treat over open wounds.
Only treat over known benign lesions.
Use caution when treating over hair bearing areas, as the laser energy may affect hair growth.
Refer to the Operator Manual for a complete list of contraindications, warnings, and precautions.

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