8501-00-1800, Revision 05
Confidential
B-3
Candela Corporation
AlexTriVantage Laser System
Pigmented Lesions
The laser exposure dosage applied to treat pigmented lesions may be in the range of 5.0 to
6.0 J/cm2. The laser exposure dosage will vary depending upon whether the melanin in the
lesion is epidermal or dermal in depth.
Clinical evidence to date suggests that the majority of epidermal lesions (lentigines and
freckles) respond to fluences between 5.0 and 6.6 J/cm2.
Dermal lesions may require higher fluences for complete clearance. It is recommended that
these lesions be tested at fluences between 5.0 and 6.6 J/cm2 and the response evaluated
before using higher energies. Clinical effects of fluences higher than 12.0 J/cm2 are not yet
known. Therefore, it is not recommended to use fluences over 12.0 J/cm2.
The size of the treatment area for the second and/or subsequent visits is directly related to
patient tolerance, success with the test site, and the rate of clearing.
Determining the End of Treatment
Laser therapy may be conducted over multiple treatment sessions. Determining the end of
treatment is left to the physician's judgment. The factors involved in this decision relate to the
clearance (or lightening) of the tattoo or pigmented lesion and the restoration of normal skin
color and texture. Often the decision to end treatment is arrived at jointly between the
physician and the patient (or parents or guardians, as applicable). Treatment should cease
when the tattoo or pigmented lesion is completely cleared or no further progress is being
obtained. Poor patient compliance with post-treatment protocol, which could jeopardize the
results of treatment, should also be considered a reason for ending treatment.
Adverse Effects
Treating the tattoo or pigmented lesion with excessive energy levels can result in adverse
effects such as hypertrophic or atrophic scarring and/or hypo- or hyperpigmentation. Patients
with darker skin types (>IV), or who are deeply tanned, may be more susceptible to
hypopigmentation at effective treatment dosages.
Warning: Treating the tattoo or pigmented lesion with excessive energy
levels may result in adverse effects such as scarring (hypertrophic and/or
atrophic) and/or hypo- or hyperpigmentation. Care must be taken when
choosing the energy density for treatment. Each laser pulse should only be
delivered within the tattoo or pigmented lesion area.
Summary of Contents for AlexTriVantage
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