Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories

The Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories (VersaPulse PowerSuite, Lumenis Pulse 30H, Lumenis Pulse 50H, Lumenis Pulse 60H, Lumenis Pulse 100H and Lumenis Pulse 120H) are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery.

The Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories are indicated for use in the performance of specific surgical applications as follows:
Urology
• Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser enucleation of the prostate (HoLEP), holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH)
• Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of:
  o bladder;
  o superficial and invasive bladder, urethral and ureteral tumors;
  o condylomas;
  o lesions of external genitalia;
  o ureteral and penile hemangioma;
  o ureteral strictures;
  o bladder neck obstructions
• Urinary Lithotripsy including:
  o endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) calculi, including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones;
  o treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed.

Arthroscopy
• Arthroscopy (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including:
  o meniscectomy;
  o plica removal;
  o ligament and tendon release;
  o contouring and sculpting of articular surfaces;
  o debridement of inflamed synovial tissue (synovectomy);
  o loose body debridement;
  o chondromalacia and tears;
  o lateral retinecular release;
  o capsulectomy in the knee;
  o chondroplasty in the knee;
  o chondromalacia ablation.
• Discectomy including:
  o percutaneous vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine; open and arthroscopic spine procedures; foraminotomy.

General Surgery
• Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including:
  o cholecystectomy;
  o lysis of adhesions;
  o appendectomy;
  o biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon;
  o skin incision;
  o tissue dissection;
  o excision of external tumors and lesions;
  o complete or partial resection of internal organs, tumors and lesions;
  o mastectomy;
  o hepatectomy;
  o pancreatectomy;
  o splenecto

The Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories (VersaPulse PowerSuite, Lumenis Pulse 30H, Lumenis Pulse 50H, Lumenis Pulse 60H, Lumenis Pulse 100H and Lumenis Pulse 120H) are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery.

The Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories (also referred to as 'Lumenis Family of Holmium Surgical Lasers'), subject of this submission, is a family of single wavelength holmium (Ho:YAG) lasers manufactured by Lumenis Ltd. The family is composed of two main series; the VersaPulse PowerSuite series (VPPS) which includes the VersaPulse PowerSuite 20W, VersaPulse PowerSuite 30W, VersaPulse PowerSuite 45W, VersaPulse PowerSuite 60W, VersaPulse PowerSuite 80W and VersaPulse PowerSuite 100W, cleared under K011703, together with the VersaPulse P20 cleared under K100228, and the modern Lumenis Pulse series which includes the recently cleared Lumenis Pulse 120H system (K140388) and further expanded with the addition of the Lumenis Pulse 30H, Lumenis Pulse 50H, Lumenis Pulse 60H and Lumenis Pulse 100H, subjects of this submission. The modifications to the subject Lumenis Family of Holmium Surgical Lasers include addition of modernized family members as well as updates to existing systems. Mainly, the subject additional devices are basically similar to the previously cleared Lumenis Pulse 120H (LP120H, recently cleared under K140388). The modified Lumenis Pulse 30H, Lumenis Pulse 50H, Lumenis Pulse 60H and Lumenis Pulse 100H systems rely on the same fundamental underlying technology of the cited predicate systems with the laser power outputs similar to the previously cleared configurations of the VersaPulse PowerSuite series cleared under K011703. The subject device modifications involve both hardware (HW) and software (SW) elements, whereas the functional capabilities of the laser systems remain unaltered in both the modified and cleared systems. The Lumenis Lumenis Pulse 60H and 120H are provided with the Moses Mode, based on the well-known Moses Effect, which limits the attenuation of holmium laser energy in the liquid environment, thus reducing dependency of the fiber positioning (i.e. distance) in respect to the target tissue. All other characteristics of the laser emission are maintained identical as in the cleared Regular Mode. All of the modified Lumenis Family of Holmium Surgical Lasers are solid state Single Wavelength (Holmium) surgical laser, comprised of the following functional components: Laser Console, Dual or single pedal Footswitch, Variety of Fiber Optic Delivery Devices (fibers) and accessories, An integrated suction pump and accessories (Lumenis Pulse 120H and Lumenis Pulse 60H). The systems are operated a