# K990947: Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND: Yag Surgical Lasers and Delivery - Pathway: 510(k) (Traditional) - Applicant: Lumenis, Inc. - Decided: Apr 27, 1999 after 36 days - Product code: GEX (Powered Laser Surgical Instrument) - Device class: 2 - Regulation: 21 CFR 878.4810 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 4 generations back to K936109 (1994). 22 ancestors in all. 350 later devices descend from it; 5 cite it directly. 0 of 373 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K980685: Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag Lasers, Lumenis, Inc. (1998) Summary page 1. - K933318: Coherent Versapulse 2.1U /1.06U Compact Surgical Laser, Models a & B, Lumenis, Inc. (1994) Summary page 1. - K932981: Coherent Versapulse 2.1 Holmium Surgical Lasers, Coherent Medical Group (1994) Summary page 1. - K923575: Coherent Versapluse 2.1 Holmium Surg. Lasers, Coherent Medical Group (1993) Summary page 1. - K914991: Versapulse (TM) Twopointone/XE Holmium Surg Lasers, Coherent Medical Group (1992) Summary page 1. - K914136: Coherent Versapulse (TM) 2.1XE/2.1L Holmi Surg Lase, Coherent Medical Group (1992) Summary page 1. - K910037: Coherent Holmium:Yag Surgical Laser, Coherent Medical Group (1991) Summary page 1. - K902990: Coherent Holmium:Yag Surgical Laser, Coherent Medical Division (1990) Summary page 1. - K895518: Coherent Holmium:Yag Surgical Laser, Lumenis, Inc. (1989) Summary page 1. - K960413: Coherent Slimline Single Lumen Aspiration Needle Kit, Lumenis, Inc. (1996) Summary page 1. - K974789: Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L, Lumenis, Inc. (1998) Summary page 1. - K952006: Accu-Beam Fiber Optic Handpiece, Tti Medical (1995) Summary page 1. ## Most influential descendants - K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices (2001), 342 descendants of its own - K083616: Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag Lasers (2009), 136 descendants of its own - K083215: Incisive Family of Inpulse ND:Yag Lasers (2009), 136 descendants of its own - K093545: Pinpointe Footlaser Model 6W, 30W, 100W (2010), 122 descendants of its own - K103626: Cutera Genesisplus Laser System (2011), 121 descendants of its own ## Indications for use The modified and currently marketed Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers 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: Ho:YAG - urology; urinary lithotripsy; arthroscopy; discectomy; endonasal surgery; gynecological surgery; and general surgery; and Nd:YAG - urology; general surgery; gastroenterology; thoracic and pulmonary surgery; ENT surgery; podiatry; orthopaedics; and with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy. The modified and currently marketed Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in the performance of specific surgical applications in urology, urinary lithotripsy, arthroscopy/orthopaedics, discectomy, endonasal surgery/ENT surgery, gynecological surgery/gynecology, general surgery, gastroenterology, thoracic and pulmonary surgery, dermatology and plastic surgery, podiatry, and limited indications in gynecology, neurosurgery, ophthalmology, and lumbar discectomy as follows: Ho:YAG - Urology Endoscopic holmium laser resection of the prostate (HoLRP) with the VersaPulse Select Ho:YAG and Ho:YAG/Nd:YAG Surgical Lasers for treatment of benign prostatic hypertrophy (BPH). Ho:YAG - Urology - Continued Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of: - bladder; - urethral and ureteral tumors; - condylomas; - lesions of external genitalia; - urethral and penile hemangioma; - urethral strictures; - bladder neck obstructions. Urinary Lithotripsy including: - endoscopic fragmentation of urinary calculi in the ureter or ureteropelvic junction; - treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed. Nd:YAG - Urology Urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including: - removal of superficial bladder tumors; - removal of invasive bladder carcinoma; - removal of benign or malignant lesions of the external genitalia, including condylomas; - treatment of urethral strictures; - treatment of vascularities of the bladder wall; - prostatectomy. Ho:YAG - Arthroscopic Surgery / Arthroscopy Arthroscopy (ablation, excision and coagulation of soft tissue) in various joints of the body, excluding the spine, including: - meniscectomy; - plica removal; - ligament and tendon release; - contouring and sculpting of articular surfaces; - debridement of inflamed synovial tissue. Discectomy including: - percutaneous vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine; - open and arthroscopic spine procedures. Nd:YAG - Orthopaedic Surgery Arthroscopy (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: Knee - capsulectomy in the knee; - chondroplasty in the knee; - plica removal in the knee; - lateral ligament release in the knee; - meniscectomy in the knee; - synovectomy in the knee; - osteoarthritic lesion removal in the knee; Shoulder - coracoacromial release in the shoulder; - debridement of scar tissue in the shoulder; - adhesive capsule release in the shoulder; - labral tear repair in the shoulder; - synovectomy in the shoulder. Discectomy: - limited to open, percutaneous and arthroscopic vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine in patients with: - unilateral leg pain greater than back pain; - paresthetic discomfort in a specific dermatomal distribution; - positive straight leg raising test and/or positive bowstring sign; - possible neurologic finding including wasting, weakness, sensory alteration and reflex alteration; - no improvement after at least 6 weeks of conservative therapy; - positive CT or MRI showing a subligamentous herniation at the location consistent with clinical findings. Ho:YAG - General Surgery Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including: - cholecystectomy; - lysis of adhesions; - appendectomy; - removal of benign and malignant lesions; - biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon. Nd:YAG - General Surgery Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - cholecystectomy; - mastectomy; - hepatectomy; - pancreatectomy; - splenectomy; - hemorrhoidectomy; - thyroidectomy; - parathyroidectomy; - herniorrhaphy; - tonsillectomy; - appendectomy; - lymphadenectomy; - partial nephrectomy; - pilonidal cystectomy; - resection of lipoma; - pelvic adhesiolysis; - removal of lesions; - removal of polyps; - removal of tumors; - tumor biopsy; - debridement of decubitus ulcers. Ho:YAG - Endonasal Surgery Endoscopic endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including: - partial turbinectomy; - ethmoidectomy; - polypectomy; - maxillary antrostomy; - frontal sinusotomy; - sphenoidotomy. Nd:YAG - Ear, Nose and Throat (ENT) Surgery Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal tissues; - tonsillectomy; - adenoidectomy. Ho:YAG - Gynecological Surgery Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue). Nd:YAG - Gynecological Surgery Gynecological surgery limited to: - treatment of menorrhagia by the photocoagulation, vaporization, or ablation, of the endometrial lining of the uterus under direct hysteroscopic visualization; - intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation, and/or vessel coagulation; - intra-abdominal treatment of endometriosis and/or peritoneal adhesions with laser contact tips; - soft tissue excisional procedures such as excisional conization of the cervix. Nd:YAG - Gastroenterologic Surgery Gastroenterologic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - partial removal of neoplastic tissue in the management of esophageal obstruction for symptomatic relief of dysphagia; - gastrointestinal hemostasis including, varicies, esophagitis, esophageal ulcer, Mallory-Wiess tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, and gastric erosions; - gastrointestinal tissue ablation of benign and malignant neoplasm, hemorrhoids and polyps. Nd:YAG - Thoracic and Pulmonary Surgery Thoracic and pulmonary surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including treatment of: - laryngeal lesions; - airway obstructions including carcinoma; - polyps and granulomas; - palliation of obstructing carcinomas of the tracheobronchial tree. Nd:YAG - Dermatology and Plastic Surgery Dermatology and plastic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - lesions of skin and subcutaneous tissue; - telangiectasia; - port wine lesions; - spider veins; - hemangiomas; - plantar warts; - periungual and subungual warts; - removal of tattoos; - debridement of decubitus ulcer; - treatment of keloids. Nd:YAG - Podiatry Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: - matrixectomy; - plantar warts; - neuromas; - periungual and subungual warts; - radical nail excision. Nd:YAG - Neurosurgery Neurosurgery limited to: - hemostasis in neurosurgery procedures such as excision of brain lesions, spinal cord lesions, cranial nerves, peripheral nerves, and pituitary glands. Nd:YAG - Ophthalmology Ophthalmology limited to: - post-vitrectomy photocoagulation. Source page: https://510kreport.com/device/K990947 Methodology: https://510kreport.com/methodology