510(k) · Cleared
ClearedTrimedyne Holmium Laser Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trimedyne, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 8, 2004 after an 82-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Sep 8, 2004
- Review
- 82 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK041660 Trimedyne Holmium Laser SystemsTrimedyne, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK183563 Holinwon 30Wontech Co., Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K183563Holinwon 30Wontech Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041660 | Trimedyne Holmium Laser Systems | Trimedyne, Inc. | 2004 | — |
| +1 | K183563 | Holinwon 30 | Wontech Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Trimedyne Holmium Laser System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183563 | Holinwon 30 | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K183563 (Wontech Co., Ltd., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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…
Read the full statement (599 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K041660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041660: Trimedyne Holmium Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041660
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026