Secret PRO

Indications for Use: Secret PRO CO2 Laser is indicated for Fractional Mode: ablative skin resurfacing and for Surgical Mode: incision, excision, ablation, vaporization and coagulation of soft body tissue, including intraoral tissue, in fields including aesthetics (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. Secret PRO RFMN is FDA cleared for dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Contraindications: Patients using a pacemaker or another implantable metal medical device; Patients with an unknown skin disease; Pregnant women; Patients who have a piercing on the treatment area; Patients with a hemostatic disorder; Patients who are receiving treatment for skin cancer or have a history of cancer; Patients who have symptoms such as sores, psoriasis, eczema, or a rash on the treatment area; Patients who are sensitive to hot sensation or who have any type of suspected lesions on the treatment area; Patients who have any immunosuppressive disease such as AIDS and HIV or any immune system disorder due to the use of immunosuppressants.

Important Safety Information: The following treatment-related expected transient side effects and possible adverse events may occur during or following treatment with Secret ™ PRO: Discomfort/Pain; Redness; Swelling;Crusting/Peeling, Milia/Acne, Skin color changes, Wounds, Contact/Allergic dermatitis or skin sensitivity, Infection, Scarring, Treatment Pattern, Petechiae, Dilated Pores, Allergies, or Ectropion. Do not use Secret ™ PRO if you are pregnant, have a cardiac pacemaker, implantable metal or medical device in treatment area, or active condition in the treatment area such as sores, psoriasis, eczema, or rash. Additional contraindications can be discussed during a treatment consultation.

Precautions: Before treatment, make sure to check the patient’s skin condition and disinfect the area to be treated to remove any foreign substances. Before treatment, inform the patient of any matters they must be aware of before, during and after treatment and ensure that the patient understands the risk of an unintended adverse event. Treat only known benign lesions. (Do not treat dysplastic nevus or suspected pigmented lesions). Treatment should not be performed on an area of skin with a tattoo or permanent make-up. Special caution should be exercised for the following patients during treatment. Patients who have received a Botox/collagen/fat dissolving injection or augmentation through the injection of a substance into the treatment area in the last six months. Refer to the Operator Manual to view the laser safety labels of the product.

Warnings: DISCOMFORT/PAIN – Mild discomfort and/or pain may occur during treatment. A topical anesthetic may have to be applied to the skin of the patient before treatment. Other types of anesthetics or agents may be used for pain management. SWELLING – Swelling/edema may occur on the treated area. This usually disappears within a few days. REDNESS – Redness/erythema may occur on the treated area. This usually disappears within approximately two weeks. MILIA/ACNE – Ointments that block hair follicles, sweat pores, and sebaceous ducts may cause milia or acne formation. Such symptoms occur more frequently in patients with a history of cystic acne or oily skin. SKIN COLOR CHANGES – The treated area may become brighter (hypopigmentation) or darker (hyperpigmentation) than the surrounding skin areas during the healing process. A color change is usually a temporary symptom, but can be permanent in rare cases. Patients should avoid exposing their skin to UV rays as much as possible and
apply sunblock after treatment. WOUNDS – Burning, blistering, or bleeding may occur in the treated area. Since these symptoms may lead to permanent scarring or infection, the patient should avoid picking at or scratching the treated area. CONTACT/ALLERGIC DERMATITIS OR SKIN SENSITIVITY – The damaged skin surface may increase the risk of skin sensitivity, skin irritation/itching, or allergic skin reactions. INFECTION – The damaged skin surface may induce an infection, leaving a scar. Wounds should be properly managed and the treated area should be kept clean. SCARRING – Scarring may occur in rare cases when the skin surface is damaged. TREATMENT PATTERN – A spot size pattern may be left on the treated area. This usually disappears over time but may remain permanently in rare cases. PETECHIAE – Petechiae may be seen for a few weeks after healing, and disappears over time without separate treatment. DILATED PORES – The collagen contraction which occurs as part of the skin resurfacing process may lead the skin to contract between pores, dilating existing pores. This symptom may be permanent in rare cases. SUN EXPOSURE / TANNING BEDS / ARTIFICIAL TANNING – Exposure to the sun, tanning beds, and artificial tanning may increase the risk of side effects and adverse events. ALLERGY – There may be an allergic reaction to topical anesthetics or metal needles. ECTROPION – Ectropion may occur very rarely in patients receiving treatment around the eyelids.