# K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices - Pathway: 510(k) (Traditional) - Applicant: Lumenis - Decided: Aug 29, 2001 after 89 days - Product code: GEX (Powered Laser Surgical Instrument) - Device class: 2 - Regulation: 21 CFR 878.4810 - Recalls of this device: 2 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K936109 (1994). 29 ancestors in all. 342 later devices descend from it; 19 cite it directly. 0 of 372 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K990947: Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND: Yag Surgical Lasers and Delivery, Lumenis, Inc. (1999) Summary page 1. - K002308: Omnipulse Holmium Laser System, Model 1210; Omnipulse Max Holmium Laser System, Model 1210-VHP and 1500-a, Trimedyne, Inc. (2000) Summary page 1. - K984591: Dornier Medilas H/2, Dornier Surgical Products, Inc. (1999) Summary page 1. - K951910: Odyssey HO:Yag Surgical Laser Systems & Accessories, Xintec Corporation (1995) Summary page 1. ## Most influential descendants - 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 - K014290: Entec Plasma Wands (2002), 119 descendants of its own ## Recalls of this device - Dec 18, 2007 · Not classified · Z-0585-2008: Incorrect Label: The Units outer pouch is labeled 200 micro fiber however, the inner pouch's label affixed to the product indicated that it is a 365 micron fiber. The micron fiber contained in the inn - Aug 29, 2006 · Not classified · Z-0028-2007: Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation (detachment of the metal cap, and the fiber lasing straight) during use. ## Indications for use The modified and the currently marketed VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with accessories 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; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery. • Nd:YAG- urology; general surgery; gastroenterology; thoracic & pulmonary surgery; E.N.T. surgery; podiatry; orthopaedics; dermatology and plastic surgery and with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy. The modified and the currently marketed VersaPulse PowerSuite Holmium (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with accessories are indicated for use in the performance of specific surgical applications in urology, urinary lithotripsy, arthroscopy/orthopaedics, discectomy, E.N.T. surgery, gynecological surgery/gynecology, general surgery, gastroenterology, thoracic and pulmonary surgery, dermatology and plastic surgery, podiatry, and limited indications in neurosurgery and ophthalmology as follows: Ho:YAG - 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: bladder; superficial and invasive bladder, urethral and ureteral tumors; condylomas; lesions of external genitalia; ureteral and penile hemangioma; ureteral strictures; bladder neck obstructions. Urinary Lithotripsy including endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) calculi, including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones; 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 — Arthroscopy Arthroscopy (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large 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 (synovectomy); loose body debridement; chondromalacia and tears; lateral retinecular release; capsulectomy in the knee; chondroplasty in the knee; chondromalacia ablation. Discectomy including percutaneous vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine; open and arthroscopic spine procedures; foraminotomy. 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; biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon; skin incision; tissue dissection; excision of external tumors and lesions; complete or partial resection of internal organs, tumors and lesions; mastectomy; hepatectomy; pancreatectomy; splenectomy; thyroidectomy; parathyroidectomy; herniorrhaphy; tonsillectomy; lymphadenectomy; partial nephrectomy; pilonidal cystectomy; resection of lipoma; debridement of decubitus ulcer; hemorrhoids; debridement of statis ulcer; biopsy. 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 - E.N.T. Surgery Endoscopic endonasal/sinus surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including partial turbinectomy; ethmoidectomy; polypectomy; maxillary antrostomy; frontal sinusotomy; sphenoidotomy; dacryocystorhinostomy (DCR); functional endoscopic sinus surgery (FESS). Nd:YAG - E.N.T. 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. Ho:YAG - Gasteroenterology Surgery Open and endoscopic gasteroenterology surgery (ablation, vaporization, incision, excision, resection, coagulation and hemostasis, including gall bladder calculi; biliary/bile duct calculi; benign and malignant neoplasm; polyps; colitis; ulcers; angiodysplasia; hemorrhoids; varices; esophagitis; esophageal ulcer; Mallory-Weiss tear; gastric ulcer; duodenal ulcer; non-bleeding ulcer; gastric erosions; colorectal cancer; gastritis; bleeding tumors; pancreatitis; vascular malformations; telangiectasias; telangiectasias of the Osler-Weber-Renu disease. Nd:YAG - Gastroenterology Surgery Gastroenterology 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. Ho:YAG - Pulmonary Surgery Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision, excision and coagulation of soft tissue). 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. Ho:YAG — Dermatology and Plastic Surgery Incision, excision, resection, ablation, coagualation, hemostasis and vaporization of soft, mucosal, fatty and cartilaginous tissues, in therapeutic plastic, dermatologic and aesthetic surgical procedures, including scars; tattoo removal; vascular lesions; port wine stains; hemangioma; telangiectasia of the face and leg; rosacea; corns; papillomas; basal cell carcinomas; lesions of skin and subcutaneous tissue; plantar warts; periungual and subungual warts; debridement of decubitus ulcer; skin tag vaporization. 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/K011703 Methodology: https://510kreport.com/methodology