Firma – Intended Use
The Firma by Eclipse is a noninvasive device intended for use in Dermatologic and General Surgical procedures.
The applicator is indicated for mild to moderate facial wrinkles and rhytides.
Treatment with the device is contraindicated for patients with any of the following conditions:
- Subjects with implanted pacemakers, arrhythmias or any other known severe heart disorder
- Subjects with any implantable metal device in the treatment area.
- Subjects on any medication that would affect the characteristic of the skin (medical or hormonal), such as Isotretinoin (Accutane) within the past two months.
- Subjects who have any form of suspicious lesion in the treatment area.
- Pregnant or lactating subjects.
- Subjects with body piercing (in the treated area).
- Subjects who suffer from autoimmune disorders or diabetes.
- Subjects using blood thinning medications.
- Subjects with clotting disorders.
- History of any kind of cancer.
- Impaired immune system due to immunosuppressive diseases such as AIDS and HTV, or use of immunosuppressive medications.
- Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime.
- Any active condition in the treatment area, such as sores, Psoriasis, eczema, and rash.
- History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
- Face lift or eyelid surgery within a year prior to treatment.
- Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated.
- Botox®/collagen/fat injections or other methods of augmentation with injected material in the treated area within 1 month prior to treatment.
- Having received treatment with light, RF or other devices in the treated area within 1 month prior to treatment.
- Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen containing agents) one week before and after each treatment session.
- Any surgical procedure in the treatment area within the last 3 months or before complete healing.
- Treating over tattoo or permanent makeup.
- Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.
- In any doubt, consult a physician before conducting the treatment.
*Available in select countries. Contact an Eclipse Aesthetics International representative for details.