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The Evolve HPD 980/ 1470nm Multiwavelength Diode Laser (Evolve Dual) (and its delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The Evolve HPD Multiwavelength 980/ 1470 Diode Laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the saphenous veins in patients with superficial vein reflux. The Multiwavelength laser is further indicated for laser assisted lipolysis. The device is specifically indicated for use as follows: Ear, Nose and Throat and Oral Surgery (Otolaryngology) Arthroscopy Gastroenterology General Surgery, Dermatology, Plastic Surgery and Podiatry Urology Gynecology Neurosurgery Cardiac Surgery Pulmonary Surgery Dental Applications

The Biolitec Medical Device, Inc. Evolve HPD 980/ 1470nm Multiwavelength Diode Laser contains the same identical components as the cleared Biolitec, Inc. Evolve HPD 980/ 1470nm Multiwavelength Diode Laser (K112013).

The MegaBeam Reusable Fiber Optic Delivery System is intended for use as an accessory to any surgical laser system to vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared.

The MegaBeam Reusable Fiber Optic Delivery System for Biolitec Medical Devices, Inc. contains the identical same components and design as the device cleared under K980838 for Biolitec Inc.

The MegaBeam Endo-ENT Probe is a fiber optic delivery system intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue. It is indicated for ENT surgery for use with compatible lasers cleared for use in the desired application.

The MegaBeam Endo ENT Probe for Biolitec Medical Devices, Inc. contains the identical same components and design as the device cleared under K952772 for Biolitec Inc. There are no differences in technology and as such does not raise any new questions on safety or efficacy.

The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece is intended for use as an accessory to any surgical laser system to vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared.

The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece for Biolitec Medical Devices, Inc. contains the identical same components and design as the device cleared under K946336, K923953 and K943445 for Biolitec Inc. There are no differences in technology and as such does not raise any new questions on safety or efficacy. Additional flat/ bare (no tips) fiber optic sizes of 230µ, 365µ, 400µ and 550u are included for clearance in this submission.

The MegaBeam Endocular Probe and Aspirating Endocular Probe are intended for intraocular photocoagulation with or without simultaneous aspiration/ irrigation as an adjunct to vitrectomy surgery. Specific indications include the treatment of proliferative vitreoretinopathy, tractional retinal detachments, proliferative diabetic retinopathy, and various retinal vascular tumors.

The MegaBeam Endocular Probe and Aspirating Endocular Probe for Biolitec Medical Devices. Inc. contains the same components and design as the devices cleared under K935747 and K952340 for Biolitec Inc. except for a small change in tip size. (19 gauge to 25 gauge).

The Twister™ Side Fire Fiber Optic Delivery System is a delivery accessory used to deliver optical energy and is indicated for use in general surgical applications in combination with any SMA-compatible laser system also indicated for the same applications. It is indicated for use in hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non contact mode with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope. urethroscope, or any other viewing scope.

The Biolitec Medical Devices, Inc. Twister™ Side-Fire Fiber Optic Delivery System contains equivalent components and identical patient-contact materials as the cleared Biolitec Inc. Megabeam Lateral/ Side Fire Fiber Optic Delivery Systems.

The device is intended for endovascular coagulation of blood vessels. The device is indicated for endovascular coagulation of the Greater Saphenous vein of the thigh in patients with superficial vein reflux.

The ELVeS kit with Radial Fibers contain the following components: (1) radial fiber; (2) access needle; (3) introducer sheath/ dilator; and (4) a guidewire and is identical to that cleared under K101712.

The Radial Emitting Shaped Fiber Optic Delivery System, is intended for use as a fiber delivery system in conjunction with any surgical laser with an SMA 905 compatible connector. It is indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. The fiber is indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, neurosurgery, plastic surgery, ENT/ otolaryngology, endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux and laser assisted lipolysis with a compatible laser marketed for use in the desired application.

The Radial Emitting Shaped Fiber Optic Delivery System for Biolitec Medical Devices. Inc. contains the identical same components and design as the device cleared under K110080 for Biolitec Inc. There are no differences in technology and as such does not raise any new questions on safety or efficacy.

The Ceralas Fiber Coupled 980nm Diode Laser family (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. Indications include: General Surgery, Urology, Gynecology, Gastroenterology, Otolaryngology, Plastic Surgery, Dermatology, Podiatry, Neurosurgery/ Peripheral. Pulmonary Surgery, Arthroscopy, Cardiothoracic Surgery, Laser Assisted Lipolysis. Ophthalmology, Dental Applications, Endovenous Occlusion of the Greater Saphenous Vein.

The Ceralas 980nm family for Biolitec Medical Devices, Inc. is identical (contains the same components, technology and principles of operation and assembled by the same manufacturer) as the cleared Ceralas 980nm family for Biolitec. Inc..