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Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV

The device is a hand-held, non-ablative wrinkle treatment handpiece available with various size electrode end effectors and a detachable cord. The electrode is spring mounted into the handle. All materials used in the manufacture of the device are suitable for the use in the device and are the same materials used in the predicate product. As with the predicated device, the device is activated using a hand or footswitch based on user preference and is intended for use with the Ellman Radio-Frequency generators (K082834) labeled for the treatment of wrinkles and rhytides.

Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV Non-ablative treatment of mild to moderate facial wrinkles for skin phototypes I-IV

The purpose of this submission is to modify the Cleaning / Disinfection methods of the Non-Ablative Wrinkle Treatment Handpiece cleared as Ellman Non-Ablative Wrinkle Treatment Handpiece under K101967. The device is identical to the device cleared under K101967 Ellman International Non-Ablative Wrinkle Treatment Handpiece except for the modified Cleaning/Disinfection method.

Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV

Accessory handpiece electrode is intended for use with the Ellman Surgitron IEC120 / 4.0 Dual Radio-Frequency generator. The device is considered as an accessory to the RF generator. The generator has been cleared by the FDA under 510(k) K082834 Ellman International Non-Ablative Technique for Surgitron IEC.

- O Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV The device is also indicated for: - O Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, lumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty. - O Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, and development of skin flaps. - O Hemostasis: control of bleeding, epilation, telangiectasia. - O Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, hemostasis. - O Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.

The Ellman Surgitron is a compact source of high power RF energy to be employed for a variety of radiosurgical procedures. This action is achieved by front panel selection of waveforms and power levels. All selections are activated by push buttons with lights that give the operator feedback of operative status. The power level for each mode is indicated by the front panel digital display, which also identifies the status of self-test and monitoring. This display is interlocked with the controls to prevent operation when fail is displayed. The final output power control is made through foot and/or hand switches. Both monopolar and bipolar electrodes are provided.

Orthopedic, arthroscopic, spinal, and neurosurgical For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist. Cutting Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty. Blended Cutting and Coagulation Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps. Hemostasis and Nonablative Coagulation Control of bleeding, Epilation, Telangiectasia Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.

The Surgi-Max Electrosurgery Generator is a compact source of high radio-frequency RF energy to be employed for a variety of radiosurgery procedures. This action is actieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps, which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays, which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAILS is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are offered. The power output in the CW (Cut) mode is 120 watts into (500 ohms) a matched load. The output frequency is maintained at 4.0 MHz +/- 400Hz over all service and loading conditions includingshort and open for monopolar mode. Three output waveforms are provided: CW CUT -- Continuous wave output with average power equal to the maximum with no deliberate modulation. CUT / COAG – Deeply modulated envelope with average to peak power ratio approximately 50%. Modulation occurring at 120 or 100 Hz rate. HEMO - Deeply modulated wave with average to peak ratio approximately 50%. Modulation occurring at 120 or 100 Hz rate of square wave.

Cutting: Skin and Mucosal Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, Skin Tags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures; Blended Cutting and Coagulation: Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures, ENT procedures; Hemostasis: Control of Bleeding, Epilation, Telangicctasia; Bipolar: Pinpoint, Precise Cutting and Coagulation, Pinpoint Hemostasis in any field (Wet or Dry)

The @llman Surgitron Radiolase II is a high frequency, medium power output electrosurgical medical device. The design is similar to currently marketed electrosurgical generators and provides the essential operational modes that are most often used in medium power electrosurgical applications. The unit consists of both a nominal 50 Watt maximum output power in monopolar mode and a nominal 55 Watt maximum output power in bipolar mode, providing the capability of precision cutting, coagulation, and hemostasis in a four megacycle frequency electrical current. The unit is designed to comply with the international safety standards.