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Intended Use

For use in aesthetic and cosmetic applications requiring the ablation, vaporization, excision and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology for aesthetic applications.

Contraindications

  • Bacterial or viral infection
  • Impaired immune system
  • Isotretinoin in the past 12 months
  • Scleroderma
  • Extensive radiation therapy
  • Burns in the treatment area
  • Poor healing in the treatment area
  • Metal implants near treatment area
  • Implantable pacemaker or automatic defibrillator/cardioverter (AICD)
  • Ablative/non-ablative cosmetic intervention (deep peeling) in the past 3 months
  • Cancer; in particularly, skin cancer
  • Active collagen or vascular disease
  • Pregnancy or IVF procedure
  • Use of photosensitive medication and herbs for which 300 to 2940nm light exposure is contra-indicated
  • Diseases which may be stimulated by light at 300 to 2940nm
  • Prolonged exposure to sun or artificial tanning during the 3-4 weeks prior to and post treatment
  • History of keloids or hypertrophic scarring
  • Active infection of herpes simplex in the treatment area
  • Diabetes (insulin dependent)
  • Fragile and dry skin
  • Hormonal disorders (that are stimulated under pulsed light)
  • Use of anticoagulants
  • Epilepsy
  • History of coagulopathies
  • Immune deficiency disease or an immuno-compromised status
  • Oral or topical use of retinoids (Accutane)
  • Oral or topical use of steroids

Each Eclipse REJUVE™ module may have its own set of contraindications. Refer to each module’s clinical guide.

Potential Side Effects of Treatment

  • Discomfort – When a light/laser pulse is triggered, some patients experience various degrees of discomfort. Some patients describe the sensation as stinging, while others liken it to a rubber band snap or a burning sensation that may last for up to one hour after treatment. Most patients tolerate the sensation during treatment, but some patients may require a topical anesthetic.
  • Damage to Natural Skin Texture – In some cases, a crust or blister may form. Normal wound care should be followed.
  • Change of Pigmentation – There may be a change of pigmentation in the treated area. Most cases of hypopigmentation or hyperpigmentation occur in people with skin types IV to VI, or when the treated area has been exposed to sunlight within 3 weeks before or after treatment. In some patients, hyper-pigmentation occurs despite protection from the sun. This discoloration usually fades in three to six months, but in rare cases, (mainly hypopigmentation) the change of pigment may be permanent.
  • Scarring – There is a chance of scarring; such as, enlarged hypertrophic or keloid scars. To reduce the chance of scarring, it is important to carefully follow all pre and post-treatment instructions. Excessive Swelling – Immediately after treatment, especially on the nose and cheeks, the skin may swell temporarily. Swelling usually subsides within hours, but may continue for up to seven days.
  • Fragile Skin – The skin at or near the treatment site may become fragile. If this happens makeup should be avoided, and the area should not be rubbed (as this might tear the skin).
  • Bruising – Purpura, or bruising, may appear on the treated area which may last
    from a few hours to several days.

*Device not available in all countries. See owners manual or an Eclipse representative for additional details.

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