Safety Information

Last revised: December 8^th, 2024

Aesthetic

CO₂ Products

CO₂ lasers should only be operated by physicians trained in using the Carbon Dioxide laser (10.6 μm) wavelength. Incorrect settings or misuse can pose serious risks to both patients and operating personnel. Potential risks of CO₂ laser procedures include changes in pigmentation, infection, erythema, skin hardening, or scarring. It is essential to read and understand the operator manuals for CO₂ systems and accessories to be fully aware of the complete list of their intended use, contraindications, and risks. The use of Lumenis CO₂ lasers is contraindicated for patients who have taken isotretinoin (e.g., Accutane®) within the past 12 months, have a history of keloid formation, or demonstrate excessive or unusually prolonged erythema. Consult the system user manual for a complete list of contraindications and risks.

Stellar M22

Stellar M22 is contraindicated for patients with active infection, viral, fungal or bacterial diseases.

The use of Stellar M22 could cause redness, swelling, scarring, change of pigmentation.

Consult the system user manual for a complete list of contraindications and risks.

FoLix

Treatment should only be attempted on clean and dry skin. The treatment should not be attempted on patients with the following conditions in the treatment area: any active infections or inflammatory skin conditions, Dysplastic nevi, tattoos, open lacerations or abrasions, viral, fungal, or bacterial diseases, or a chronic dermatological condition in the scalp. The most common immediate responses of laser treatment for hair growth are erythema, edema, and hair shedding. The complete list of contraindications and risks can be found in the FoLix system user manual.

LightSheer

Treatment should not be attempted on patients with the following conditions in the treatment area: any active infections or inflammatory skin conditions, Dysplastic nevi, tattoos, active cold sores, open lacerations or abrasions, viral, fungal, or bacterial diseases or a history of post inflammatory hyperpigmentation. The most common immediate responses of laser treatment for hair removal, vascular lesions, pigmented lesions are erythema, edema, perifollicular edema and perivascular edema, vascular bleaching, hyperpigmentation and hypopigmentation or textural changes of the treated areas. The complete list of contraindications and risks can be found in the LigthSheer system user manual.

SPLENDOR X

The SPLENDOR X Laser Family is intended to be used in the professional environment by trained, licensed physicians.

Before full treatments, patients should receive test spots to evaluate their immediate and delayed skin responses and for side effects.

Laser Alex and Laser Nd:YAG treatments are contraindicated in patients on any of the medications indicated in the following list or who have any of the following conditions:

Medication that increases skin sensitivity to light; Medication that changes skin metabolism; Cancer or pre-cancerous lesions in the treatment area; Herpes simplex in the treatment area; At risk of keloid scars; Epilepsy – Possible epileptic reactions during treatment; Intense tan; Anticoagulant therapy; Mechanical or chemical hair removal six weeks prior to the laser treatment.

The following adverse side effects may appear in some patients in the treated areas:

Burns, blisters, crusting; Hypo or hyper-pigmentation (darkening or lightening of the skin); Irritation, itching, burning sensation, or pain during treatment or following treatment; Infection at the treatment site; Scarring may occur in rare cases; Transient exacerbation of hair growth; Purpura may be evident for several days following treatment; Pruritis may occur in rare cases; Contact dermatitis or irritant dermatitis may occur in some cases; Treatment of Hirsutism and PFB may cause increased hair growth in some individuals.

Based upon currently available data, the highest risk groups for this response are females of Mediterranean, Middle Eastern, and South Asian heritage when treated on the face and neck.

Although adverse side effects are rare, they may be minimized by following the operating pre and post instructions and using proper clinical techniques.

Please refer to the user manual for a complete list of intended use, contraindications, and risks.

NuEra Tight

NuEra Tight must be used in the professional environment under the supervision of use-enabled medical personnel, with knowledge of operation and all applications related to the use of the devices.

The user must ensure complete contact of the Single Use Return Plate with the patient, as partial contact may result in high local temperatures and potential skin burns of the patient. Loss of contact between the Single Use Return Plate(s) and the patient’s skin will NOT result in an alarm.

NuEra Tight is unsuitable for anyone who is pregnant, has an infection or illness, or is heat sensitive. Cuts, wounds, piercings and tattoos must be avoided and areas with injectable fillers and toxins left for a month before treatment. Patients with a metal implant or implanted device (e.g., pacemaker) must consult with a qualified physician first. If deemed suitable, the Single Use Return Plate must be placed far away from the implant. Local, oral or systemic anesthetics cannot be used before or during treatment as patients need to provide regular feedback to ensure their continued comfort. Insulate patients from metal objects, especially any in direct contact (e.g., the bed). A full practitioner consultation is always advisable.

Please refer to the user manual for a complete list of intended use, contraindications, and risks.

Ophthalmology

Photocoagulator Family

Lumenis photocoagulators and delivery devices are intended solely for use by trained physicians. It is contraindicated for eyes with severe media opacities. Risks include increased macular edema and bleeding in areas of neovascularization. Refer to the operator manual for a complete list of intended use, contraindications and risks.

Photocoagulator Products

Smart 532/ Spectra/ Array/ Vision One is intended solely for use by trained physicians. It is contraindicated for eyes with severe media opacities. Risks include increased macular edema and bleeding in areas of neovascularization. Refer to the operator manual for a complete list of intended use, contraindications and risks.

Selecta Family

SLT mode: Lumenis devices intended for Selective Laser Trabeculoplasty (SLT) in patients with open angle glaucoma, are solely for use by trained physicians.

This mode is contraindicated for eyes with neovascular or angle-closure glaucoma. Risks include iritis, conjunctivitis and IOP rise. Refer to the operator manual for a complete list of intended use, contraindications and risks.

YAG mode: Lumenis devices intended for posterior capsulotomy and laser peripheral iridotomy in patients with posterior capsule opacification and angle-closure glaucoma, respectively, are solely for use by trained physicians. This mode is contraindicated for eyes with corneal pathologies and chronically elevated IOP. Risks include IOP rise, macular edema and retinal detachment. Refer to the operator manual for a complete list of intended use, contraindications and risks. Selecta Products

Selecta Products

Selecta Duet and Digital Duet

Selecta Duet is intended solely for use by trained physicians. SLT: contraindicated for eyes with neovascular or angle-closure glaucoma. Risks include iritis, conjunctivitis and IOP rise. YAG: contraindicated for eyes with corneal pathologies and chronically elevated IOP. Risks include IOP rise, macular edema and retinal detachment. Refer to the operator manual for a complete list of intended use, contraindications and risks.

Selecta Trio and Digital Trio

Smart Selecta Trio is intended solely for use by trained physicians. SLT: contraindicated for eyes with neovascular or angle-closure glaucoma. Risks include iritis, conjunctivitis and IOP rise. YAG: contraindicated for eyes with corneal pathologies and chronically elevated IOP. Risks include IOP rise, macular edema and retinal detachment. Smart 532: contraindicated for eyes with severe media opacities. Risks include increased macular edema and bleeding in areas of neovascularization. Refer to the operator manual for a complete list of intended use, contraindications and risks.

OptiLIGHT

OptiLIGHT is contraindicated for patients with active infection, viral, fungal or bacterial diseases.

The use of OptiLIGHT could cause ocular complications if eyes are not adequately protected with eye shields, such as iritis, trans-illumination defects, pupillary defects, photophobia and pain.