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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 (up to 150W) 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. Power from 151W to 200W is indicated in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH). 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 Endovenous Occlusion of the Saphenous Veins in Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities Urology Gynecology Neurosurgery Cardiac Surgery Pulmonary Surgery Dental Applications Powers from 151W to 200W

The Evolve HPD 980/ 1470nm Multiwavelength Diode Laser contains the same basic components as the cleared Ceralas 150W 980/ 1470mm Diode Laser (K090164). The purpose of this submission is to increase the energy from 150W to 200W for application in the vaporization of the prostate to treat Benign Prostatic Hyperplasia. (BPH)

The Ceralas 1470nm Fiber-Coupled Diode Laser family (and its delivery accessories used to deliver optical energy) 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. Endovenous Occlusion of the Saphenous Veins in Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities. Laser Assisted Lipolysis.

The Ceralas 1470nm 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 1470nm family for Biolitec, Inc..

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, 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 contains the same basic components and design as the cleared Megabeam Radial fiber and theCeralas diode laser family is substantially similar in performance and technology to the cleared Nd: YAG laser.

The Ceralas Fiber-Coupled 1470nm 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. Added Indication for Use: Laser Assisted Lipolysis

The Ceralas 1470nm contains the same basic components as the cleared Ceralas 980nm family and substantially similar technologies to the cleared Quanta 980 and 1470nm families.

The device is intended for endovascular coagulation of blood vessels. The device is indicated for the endovascular coagulation of the greater saphenous vein in 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.

The Ceralas Fiber-Coupled Diode Laser family 980nm (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. Added Indication for Use: Percutaneous Lumbar Disc Decompression/ Diskectomy in soft and cartilaginous tissue.

Ceralas Fiber-Coupled Diode Laser 980 nm Family

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 Ceralas Multiwavelength 980/1470nm 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 greater saphenous vein. 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) Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include: - Removal of benign lesions from the ear, nose and throat - Excision and vaporization of vocal cord nodules and polyps - Incision and excision of carcinoma in situ - Ablation and vaporization of hyperkeratosis - Excision of carcinoma of the larynx - Laryngeal papillomectomy - Excision and vaporization of herpes simplex I and II - Neck dissection Arthroscopy Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include: - Menisectomy - Synovectomy - Chondromalacia Gastroenterology Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include: - Hemostasis of upper and lower GI bleeding - Excision and vaporization of colorectal carcinoma - Excision of polyps General Surgery, Dermatology, Plastic Surgery and Podiatry Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include: - Matrixectomy - Excision of neuromas - Excision of periungual and subungual warts - Excision of plantar warts - Excision of keloids - Liver resection - Excision of cutaneous lesions - Hemorrhoidectomy - Appendectomy - Debridement of decubitus ulcers - Hepatobiliary tumors - Mastectomy - Dermabrasion - Vaporization and hemostasis of capillary hemangioma - Excision, vaporization and hemostasis of abdominal tumors - Excision, vaporization and hemostasis of rectal pathology - Pilonidal cystectomy - Herniorapphy - Adhesiolysis - Parathyroidectomy - Laparoscopic cholecystectomy - Thyroidectomy - Resection of organs - Debridement of wounds - Photocoagulation of teleangectasia of the legs and face - Photocoagulation of vascular lesions of the face and extremities - Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux. - Treatment of reticular veins and branch varicosities Urology Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include: - Vaporization of urethral tumors - Release of urethral stricture - Removal of bladder neck obstruction - Excision and vaporization of condyloma - Lesions of external genitalia - Vaporization of the prostate to treat benign prostatic hyperplasia (BPH) Gynecology Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include: - Endometrial ablation - Excision or vaporization of condylomata acuminate - Vaporization of cervical intraepithelial neoplasia - Cervical conization - Menorrhagia Neurosurgery Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas Cardiac Surgery Hemostasis and coagulation of soft tissue, including cardiac tissue. Pulmonary Surgery Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include: - Tracheobronchial malignancy or stricture - Benign and malignant pulmonary obstruction - Endoscopic pulmonary applications Dental Applications Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening. Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

The Ceralas Multiwavelength 980/1470 Diode Laser emits laser energy at the 980nm and 1470nm wavelengths in a manner substantially similar to the Ceralas 980 and Ceralas 1470.

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 180W Ceralas D 980 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 greater saphenous vein. The device is specifically indicated for use as follows: Ear, Nose and Throat and Oral Surgery (Otolaryngology) Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include: - Removal of benign lesions from the ear, nose and throat - Excision and vaporization of vocal cord nodules and polyps - Incision and excision of carcinoma in situ - Ablation and vaporization of hyperkeratosis - Excision of carcinoma of the larynx - Laryngeal papillomectomy - Excision and vaporization of herpes simplex I and II - Neck dissection Arthroscopy Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include: - Menisectomy . - Synovectorny . - Chondromalacia . Gastroenterology Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include: - Hemostasis of upper and lower GI bleeding - Excision and vaporization of colorectal carcinoma - Excision of polyps General Surgery, Dermatology, Plastic Surgery and Podiatry Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include: - . Matrixectomy - Excision of neuromas . - Excision of periungual and subungual warts - Excision of plantar warts . - Excision of keloids ● - Liver resection . - Excision of cutaneous lesions ● - Hemorrhoidectomy . - Appendectomy - Debridement of decubitus ulcers - Hepatobiliary tumors Mastectomy Dermabrasion - Vaporization and hemostasis of capillary hemangioma - Excision, vaporization and hemostasis of abdominal tumors - Excision, vaporization and hemostasis of rectal pathology - Pilonidal cystectomy - Herniorapphy - Adhesiolysis - Parathyroidectomy - Laparoscopic cholecystectomy - Thyroidectomy - Resection of organs - Debridement of wounds - Photocoagulation of teleangectasia of the legs and face - Photocoagulation of vascular lesions of the face and extremities - Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux. - Treatment of reticular veins and branch varicosities Urology Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include: - Vaporization of urethral tumors . - Release of urethral stricture - Removal of bladder neck obstruction - Excision and vaporization of condyloma - Lesions of external genitalia - Vaporization of the prostate to treat benign prostatic hyperplasia (BPH) Gynecology Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include: - Endometrial ablation . - Excision or vaporization of condylomata acuminate - Vaporization of cervical intraepithelial neoplasia - Cervical conization - Menorrhagia Neurosurgery Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas Cardiac Surgerv Hemostasis and coagulation of soft tissue, including cardiac tissue. Pulmonary Surgery Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include: - . Tracheobronchial malignancy or stricture - Benign and malignant pulmonary obstruction . - Endoscopic pulmonary applications Dental Applications Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening. Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

The 180W Ceralas D 980 has the same technological characteristics as the cleared 150W Ceralas D 980.

The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The Ceralas D1470 contains an ELVeS Kit for gaining access to the vasculature to treat varicose veins and varicosities associated with superficial reflux of the saphenous veins.

The Ceralas E15/980, E30/980 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas E15/980, E30/980 is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, and ophthalmology. This Ceralas E15/980, E30/980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue) and laser assisted lipolysis.

The Ceralas E15/980, E30/980 has the same technological characteristics as the cleared Ceralas D. The laser has an additionally incorporated RFID sensor/antenna in the fiber port so as to recognize fibers with an RFID chip in their connectors. The fibers used with the Ceralas E have been previously cleared by FDA (K951775, K964497, K060050) for use with its other laser products and have an RFID chip incorporated into the proximal connector end.