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A global leader in the field of minimally-invasive clinical solutions for the Surgical, Ophthalmology & Aesthetic markets. World-renowned expert in developing & commercializing innovative energy-based technologies, including CO2 & Holmium Lasers, Intense Pulsed Light (IPL) & Radio-Frequency (RF) devices. VersaPulse™ PowerSuite™ Holmium Lasers . Refer to the device directions for use for complete instructions on device use. Intended Use/Indications for Use. The following applications are indicated for urology while using the Ho:YAG wavelength: • Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate MAUDE Adverse Event Report: LUMENIS LTD. VERSAPULSE POWERSUITE 100W HOLMIUM SURGICAL LASERS AND DELIVERY DEVICES AND ACCESSORIES. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Model Number VERSAPULSE POWERSUITE 100W: Device Problem Display or Visual Feedback Problem (1184) Patient Problem No Known Impact Or Consequence To Patient Specifications. Average Power: 100 Watts. Laser Source: Holmium:YAG. Wavelength: 2.1 µm. Energy per Pulse: 0.2-3.5 Joules. Repetition Rate: 5-53 Hertz. Note: Using any third-party laser fibers not listed as compatible with Lumenis Pulse™ Laser Systems and VersaPulse™ PowerSuite™ Laser Systems may void the customer's warranty. Lumenis PowerSuite 100W. The VersaPulse PowerSuite 100W was Lumenis' first high-watt holmium laser solution and a pioneer in its field. It has a successful clinical track record of over 15 years in treatment prostate enucleation (HoLEP) and stone lithotripsy. LUMENIS LTD. VERSAPULSE POWERSUITE 100W HOLMIUM SURGICAL LASERS AND DELIVERY DEVICES AND ACCESSORIES: Back to Search Results: Model Number VERSAPULSE POWERSUITE 100W: Device Problems Failure to Deliver Energy (1211); Optical Problem (3001) Patient Problem No Clinical Signs, Symptoms or Conditions (4582) It was reported by a foreign hospital that during a procedure to treat cervical intra-epithelial neoplasia (cin) where a lumenis versapulse select 80/100w laser was employed, the cloth drape was reported to have ignited resulting in the patient sustaining third degree burns; the patient is reported to have been put into icu and has required two (2) skin graft procedures. LUMENIS, LTD. VERSAPULSE POWERSUITE 80/100W HOLMIUM/YAG SURGICAL LASER: Back to Search Results: Model Number 80/100W: Device Problems Fire It was reported that at the completion of a gynecological procedure in which a lumenis versapulse select 80/100w laser was employed, the laser fiber handpiece was placed on the patient's drape. The CE mark is a certification label which allows Lumenis to sell the VersaPulse PowerSuite Lasers throughout the European community. This label certifies that the VersaPulse PowerSuite laser meets all regulations set forth by various countries in Europe. It is important to ensure that this label is on the laser chassis. 93/42/EEC 0086 1.5 The VersaPulse PowerSuite Dual Wavelength system is a powerful combination of two wavelengths - 80 Watts Holmium and 100 Watts Nd:YAG lasers which is ideal for procedures requiring high-ene