Search Results

SC Medica FFX is a lumbar facet device that is placed bilaterally through a posterior surgical approach and spans the facet interspace. SC Medica FFX must be used with an FDA-cleared transfacet screw cleared for use in the lumbar spine. SC Medica FFX is intended to provide temporary fixation to the spine as an aid to lumbar fusion through bilateral immobilization of the facet joints at one or two levels with autogenous and/or allogenic bone graft. SC Medica FFX must be accompanied with an FDA-cleared intervertebral body fusion device and/or with an FDA-cleared posterior lumbar pedicle screw and rod system implanted at the same spinal level(s) as an adjunct to a single or two-level intervertebral body or posterolateral fusion, respectively. SC Medica FFX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L3 to S1 in skeletally mature patients who have failed conservative care.

FFX implants are intended to provide temporary fixation and stabilization to the spine as an aid to lumbar fusion through bilateral immobilization of the facet joints. The FFX implant is a sterile, single patient use, long-term implantable device made of titanium.

ESC Intense Pulsed Light Systems: EpiLight® and MultiLight™, are used for the removal of unwanted hair from all skin types.

Not Found

EpiLight® and PhotoDerm® HR are used for the removal of unwanted hair. EpiLight® and PhotoDerm® HR are also intended to effect stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.

EpiLight® and PhotoDerm® HR are electro-optical medical devices designed for effective photothermal treatment of unwanted hair and its removal.

The modified LX-20 Laser System Family is a general surgical instrument used to vaporize, incise, excise, ablate, or photo coagulate soft tissue in surgical procedures in the listed surgical specialties. The system may be effectively utilized for those applications recognized as within the accepted indications for use of C0, laser devices performed within the listed specialties and which require power densities as calculated by power and spot size referenced in the power density charts in the operator's manual. Indications for Use - Gynecology Representative examples: Condyloma, excision and vaporization, cervical, vulvar, & perineal; vaginal intraepithelial neoplasia ablation (VAIN); vulvar intraepithelial neoplasia ablation (VIN); herpes vaporization; urethral caruncle vaporization; I&D Bartholin's & nubothian cysts. Indications for Use - Laparoscopic Surgery Vaporization, incision, excision, ablation, or photo coagulation of soft tissue in endoscopic and laparoscopic surgery including GYN laparoscopy where delivery of energy by the hollow fiber may be more convenient than delivery of energy by a handpiece. Representative examples: endometriosis ablation; excision of adhesions; salpingotomy; metroplasty, Indications for Use - Dermatology Representative examples: Tattoo removal; port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; keloid reduction; wart removal; basal & squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas, hemangiomas, nevi, and tricoepitheliomas; dermabrasion such as for lentigos, keratoses, actinic keratosis & cheilitis. Indications for Use - Dental/Oral Surgery Representative examples: Gingivectomy; frenum release; removal of soft tissue, cysts, and tumors. Indications for Use - Orthopedic Representative examples: Menisectomy; chondromalacia ablation; partial synovectomy; lateral release; PMMA removal. Indications for Use - General Surgery Representative examples: Hemorthoid removal; skin tag vaporization; pilodidal cyst removal and repair: debridement of decubitus ulcers and statis ulcers; mastectomy, breast biopsy, reduction mammoplasty; cytoreduction for metastatic disease; many dermatological procedures. Indications for Use - Otorhinolaryngology (ENT) Representative examples: Subglottic stenosis vaporization; tonsillectomy; removal of vocal cord papillomas, nodules, and polyps; lymphangioma removal; pulmonary bronchial and tracheal lesion removal: turbinectomy; removal of leukoplakia of larynx; ablation of choanal atresia. Myringotomy/tympanostomy; Laser Assisted Uvulopalatoplasty (LAUP). Indications for Use - Podiatry Representative examples: Plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neruoma removal; ingrown nail treatment.

The Luxar modified LX-20 Surgical Laser System produces laser (infrared) energy at a wavelength of 10.6 microns which is directed to soft tissue through a knuckled beam delivery assembly, articulated arm or articulated arm plus hollow fiber waveguide, handpieces, and sterile delivery tips.

The ESC Diode Laser System is intended for the treatment of vascular and pigmented lesions including leg veins.

The ESC Diode Laser System is a semiconductor diode laser system operating at the 830nm wavelength

The Derma™ K Laser System is intended for incision, ablation, vaporization, and hemostasis of soft tissue.

Not Found

The PhotoDerm® HR is intended for the removal of unwanted hair. The PhotoDerm® HR is used for the removal of unwanted hair.

PhotoDerm® HR is an electro optic medical device designed for effective photothermal treatment of unwanted hair and its removal.

The PhotoDerm® Nd: YAG accessory is intended for coagulation and hemostasis of vascular lesions and soft tissue.

The Nd: YAG laser accessory is a pulsed medical laser operating at a wavelength of 1064 nanometers. The device is operated by the PhotoDerm® system and emits high energy pulses of 1- 10 ms duration and up to 150 j/cm2. The Nd: YAG laser accessory is a hand held device that replaces the standard optical treatment head used in the PhotoDerm® machines.

The Derma™ K laser system is intended for incision, excision, ablation, vaporization and hemostasis of soft tissuc.

The Derma™ K is a surgical laser system that produces laser (infrared) energy at wavelengths of 2.94 and 10.6 microns which is directed to soft tissue through an articulated arm system with removable handpieces.

The DermaScan™ Surgical Laser Scanner is intended for use in soft tissue ablation procedures.

DermaScan™ Surgical Laser Scanner is a microprocessor controlled device that converts a surgical laser device into an advanced aesthetic surgery tool for a variety of cosmetic procedures. The device uses motorized mirrors to deflect a laser beam over a specified area in a uniform and controlled manner. Using a sophisticated interface the user can specify a large number of parameters to achieve a scanning procedure that is tailored to the individual needs of the patient. The scanner then controls the actual tissue ablation process to achieve a uniform removal of tissue over the entire area. An aiming beam is used to outline the treated area