INDICATIONS FOR USE
The Clear + Brilliant Laser System is indicated for use in aesthetic procedures requiring the coagulation of soft tissue, as well as for general skin resurfacing procedures. In the skin, water is the primary absorber (chromophore) of the laser wavelength used in Clear + Brilliant. It can be safely used on all skin types.
Clear + Brilliant includes an Intelligent Optical Tracking System (IOTS™) that senses skin contact with the treatment tip rollers, and the motion of the tip relative to the skin surface. This feature ensures safety and uniform delivery of the treatment. Your treatment provider will perform a pre-treatment consultation and decide, together with you, if Clear + Brilliant is adequate for you and the course of treatments will need.
COMPLAINTS AND ADVERSE EVENTS
Solta Customer Service should be contacted if Clear + Brillaint is involved in a complaint or adverse event.
There is a very low incidence of side effects and complications associated with laser treatment. The following complications are very rare but may be associated with non-ablative laser treatments in general. This is not intended to be an all-inclusive list, nor a substitute for informed consent, which should be provided by every individual.
Description of Possible Complications
Discoloration or the possibility of temporary and permanent skin color change is known to exist with any laser treatment. Post-inflammatory hypo-pigmentation and hyper-pigmentation are known complications of many laser treatments and may occur with Clear + Brilliant laser treatment. Following appropriate instructions for sun protection will lower the risk for pigmentation changes.
- Infection – A risk of infection exists whenever the skin is wounded. The possibility for infection exists even with non-ablative fractional laser devices such as Clear + Brillaint. If observed, infection should be treated appropriately with topical and/or systemic medications.
- Prolonged Redness – Mild-moderate transient erythema is an expected response with any laser treatment. However, if erythema is severe or persists significantly longer than expected, re-treatment should be avoided until the condition resolves. Reaction may vary on a person-to-person basis.
- Burns/Blistering – The base of all laser treatments is the heating of soft tissue in a controlled manner. Extended burns and/or blisters should be treated appropriately with appropriate medications.
- Scarring – The possibility for scarring exists with any laser treatment, even with non-ablative laser devices such as Clear + Brillaint. Local scarring may occur directly from laser exposure if treatment procedures are not followed properly, or from infection or physical irritation such as picking and rubbing.
- Delayed Wound Healing / Skin Textural – Changes Following any laser treatment, re-epithelialization may not occur as expected due to an individual’s physiology (i.e. poor wound healing ability, or post-treatment care). This may result in undesirable textural changes.
- Temporary Bruising – Temporary bruising may develop over the treated areas.
Sun exposure before and during treatment can increase the risk of unwanted pigmentation. After treatment the skin is more sensitive to the sun, which can increase the risk of unwanted pigmentation and sunburn. Post-treatment individuals should plan to use a high SPF sunscreen on a regular basis. Ideally, a dual UVA/UVB sunscreen should be applied containing both a physical sun block (either or both zinc oxide or titanium dioxide) with a sun protection factor of 15 of above. Applying sunscreen helps maintain good results. In general, it is recommended that direct sunlight is avoided and to wear sun-protective clothing (i.e. a wide-brimmed hat) when possible.
Not all individuals will necessarily react the same way to the laser treatment.
The following (but not limited to) contraindications are routine for many laser treatments and may also be associated with Clear + Brilliant treatments. Your provider will perform a pre-screening and request you to sign a consent including these (but not limited to) contraindications:
- diagnosis / possibility of actinic keratosis, melasma, rosacea, or other significant skin conditions (e.g. skin cancer, active infections, cold sores, open wounds, rashes, burns, inflammation, eczema, psoriasis),
- predisposition to keloid formation or excessive scarring,
- diagnosis of a condition that may compromise the immune system, such as HIV, lupus, scleroderma, and/or systemic infections,
- known sensitivity to light or if photosensitizing agents/medications are being taken,
- systemic steroids (e.g. prednisone, dexamethasone), which should be rigorously avoided prior to and throughout the course of treatment,
- use of retinoids should be avoided for at least 2 weeks prior to and during treatment,
- individuals undergoing Accutane™ (Isotretinoin) treatment or with drugs in a similar class,
- if skin is still recovering from a cosmetic procedure, such as a chemical or mechanical peel, or laser resurfacing,
- if Botox injections, or dermal fillers (such as collagen) have occurred within the past 2 weeks.
- Solta Medical Inc. has no clinical information or experience concerning the use of Clear + Brilliant on pregnant women or nursing mothers.
EXPECTED RESPONSES TO TREATMENT
Expected Responses Description
- Erythema (Redness) – Mild to moderate erythema (redness) typically develops immediately after treatment and diminishes or resolves within 12 to 24 hours after treatment. A small degree of redness may last longer in some cases.
- Edema (Swelling) – Mild to moderate edema (swelling) typically develops immediately after treatment and diminishes or resolves within 12 to 24 hours after treatment. A small degree of swelling may last longer in some cases.
- Itching / Dryness – These are common symptoms once the skin has healed initially. Flakiness and dry crusting will gradually clear. Use of bland moisturizers and/or sunscreens that have previously been shown to not cause irritation should help this condition.
- Increased Skin Sensitivity – The skin can become more sensitive to touch and temperature changes. This is a sign that the skin is regenerating and daily use skin care products may be applied to soothe the skin. These sensations typically diminish within a few days after treatment.
- Pain or Discomfort – Post-treatment cooling gels, cooling masks, or handheld fans may be used to alleviate discomfort. Over-the-counter itch and pain relievers may be used if necessary (e.g. Benadryl®, Claritin®, Tylenol®, etc). Solta has no knowledge of the effects of NSAIDS (e.g. Motrin®) on the outcome of treatment.
PROTECTING YOUR NEW SKIN
For treatments associated with Clear + Brilliant, new skin (epithelium) will start to form within 24 hours but will remain covered by the old superficial layer of the skin (stratum corneum). This new skin formation usually lasts for 4 days, but can be longer for some skin types. During that time, normal exfoliation will reveal the repaired skin tissue. You can protect it by avoiding aggressive exfoliation and by applying moisturizers and sun screen frequently.
ROUTINE SKIN CARE
Most skin care products can be used the day after treatment. Avoid the use of retinoids and topical corticosteroids for 1 – 2 weeks before and after treatment. Avoid systemic steroids (e.g., prednisone, dexamethasone) throughout the course of the Clear + Brilliant treatment.