# K041660: Trimedyne Holmium Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Trimedyne, Inc.
- Decided: Sep 8, 2004 after 82 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Trimedyne Holmium Laser System: named in the summary without a submission number

## Most influential descendants
- K183563: Holinwon 30 (2019), 0 descendants of its own

## Indications for use
Superficial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications: 1. Dennatolog¥ and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars; basal cell carcinomas; tattoo removal; lesions of skin and subcutaneous tissue; vascular lesions (including port wine stains, hemangioma, telangiectasia [facial, leg], and rosacea); plantar warts; periungual and subungual warts; corns; debridement of decubitus ulcer; papillomas; skin tag vaporization 2. Gastroenterological/Gastrointestinal Surgery, including: cholecystectomy; lysis of adhesions; appendectomy; biopsy; pylorostenotomy; benign and malignant lesions; rectal polyps of sigmoid colon; 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-Rendu disease 3. General Surgery of soft tissue, including: skin incision; tissue dissection; excision of external tumors and lesions; hemiorrhaphy; tonsillectomy; lymphadenectomy; complete or partial resection of internal organs; partial nephrectomy; tumors and lesions; tissue ablation; mastectomy; hepatectomy; pancreatectomy; splenectomy; thyroidectomy; parathyroidectomy; pilonidal cystectomy; resection of lipoma; pelvic adhesiolysis; debridement of decubitus ulcer; hemorrhoids; pilodidat cyst removal and repair; debridement of statis ulcer; biopsy 4. Genitourinary Surgery/Urology, including: superficial urinary bladder tumors; mvasive bladder carcinoma; urethral strictures; lesions of the external genitalia; bladder; urethral and ureteral tumors; condylomas; urethral and penile hemangioma; bladder neck obstructions; holmium laser incision, excision, resection, ablation, hemostasis, vaporization, and enucleation in the treatment of benign ic hyperplasia (BPH) 5. Gynecological Sur2ery during open and endoscopic procedures, including: condyloma acuminata 6. Lithotripsy and Percutaneous Urinary Lithotripsy, including: fragmentation of urinary calculi; fragmentation of kidney calculi; fragmentation of urethral calculi; treatment of distal impacted fragment of steinstrasse when guide wires cannot be passed 7. Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, including: knee meniscectomy; ligament and tendon release; knee synovectomy; contouring and sculpting of articular surfaces; chondromalacia and tears; debridement of inflamed synovial tissue; loose body debridement; capsulectomy in the knee; lateral retinacular release; chondroplasty in the knee; debridement of the degenerative knee; chondromalacia ablation; plica removal 8. Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery; polypectomy; functional endoscopic sinus surgery; maxillary antrostomy; turbinate procedures (e.g.. turbinectomy); frontal sinusotomy; dacryocystorhtinostomy (DCR); sphenoidoomy; ethmoidectomy 9. Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression / Discectom: Superficial incision, excision, resection, ablation, coagulation, hemostasis and vaporization, with or without an endoscope, in the following: Percutaneous Lumbar Disc DecompressionIDiscectomy in soft, cartilaginous, and bony tissue, including: foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy in soft tissue, in patients with: uncomplicated ruptured or herniated discs; neck pain with radiation down the arm; symptoms and signs of sensory loss, tingling, numbness, muscle weakness, and/or decreased deep tendon reflexes; MRI, CT, myelog-ram, or discogram findings of disc herniation consistent with patient signs and symnptonm; positive electromyography and/or nerve conduction studies; no improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication) Percutaneous Thoracic Disc Decompression/Discectorny in soft tissue, in patients with: uncomplicated ruptured or herniated discs; thoracic and intercostal intractable pain; paresthesias at levels appropriate to the herniated discs visualized on MR[ and CT-rnyelography; MRm, CT, myelograni, or discograni findings of disc herniation consistent with patient signs and 5)'mptoInis; no improvement after 12 weeks of conservative therapy (i.e., physical therapy, traction, bed rest, exercises, and medication) Interstitial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization in multispecialty applications; interstitial applications should only be performed using the Trinmedyne Side Firingo Needle with Vent Sheath family of optical fiber delivery devices.

Source page: https://510kreport.com/device/K041660
Methodology: https://510kreport.com/methodology