# K170121: Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories

- Pathway: 510(k) (Special)
- Applicant: Lumenis, Ltd.
- Decided: May 22, 2017 after 129 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K936109 (1994). 31 ancestors in all.
17 later devices descend from it; 5 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140388: Lumenis Pulse 120H, Lumenis, Ltd. (2014) Summary page 7.

## Most influential descendants
- K183647: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories) (2019), 12 descendants of its own
- K211401: SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (2021), 7 descendants of its own
- K221306: SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories (2023), 4 descendants of its own
- K242191: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (2024), 3 descendants of its own
- K261221: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (2026), 1 descendant of its own

## Recalls of this device
- Jan 23, 2025 · Class II · Z-1290-2025: The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting

## Indications for use
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: - 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. 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; - chondrornalacia ablation. • Discectorny including: - percutaneous vaporization of the L4-5 and LS-SI 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: - 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. ENT 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). Gynecological Surgery • Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue). Gastroenterology Surgery • Open and endoscopic gastroenterology 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; - telangiectasia; - telangiectasia of the Osler-Weber-Renu disease. Pulmonary Surgery • Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision, excision and coagulation of soft tissue. Dermatology and plastic surgery • Incision, excision, resection, ablation, coagulation, 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; - papilloma; - basal cell carcinomas; - lesions of skin and subcutaneous tissue; - plantar warts; - periungual and subungual warts; - debridement of decubitus ulcer; - skin tag vaporization.

Source page: https://510kreport.com/device/K170121
Methodology: https://510kreport.com/methodology