510(k) · Cleared
ClearedOmnipulse Mini, Model 2120
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 Nov 17, 2004 after a 15-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Nov 17, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK043012 Omnipulse Mini, Model 2120Trimedyne, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK061455 Dornier Medilas H 20 LaserDornier Medtech America, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK122159 Dornier Medilas H30 SolvoDornier Medtech America, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK180350 Dornier Medilas H Solvo 35 LaserDornier Medtech America · 2018
- Descendant · 2 generations on · 0 of its ownK130344 Dornier Medilas UropulseDornier Medtech America, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK080525 Cook Odyssey Holmium Laser System, Model 30WCook Urological, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K061455Dornier Medilas H 20 LaserDornier Medtech America, Inc. · 2006 · cites it directly4descendants
- K122159Dornier Medilas H30 SolvoDornier Medtech America, Inc. · 2013 · 2 generations on2descendants
- K180350Dornier Medilas H Solvo 35 LaserDornier Medtech America · 2018 · 3 generations on0descendants
- K130344Dornier Medilas UropulseDornier Medtech America, Inc. · 2013 · 2 generations on0descendants
- K080525Cook Odyssey Holmium Laser System, Model 30WCook Urological, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043012 | Omnipulse Mini, Model 2120 | Trimedyne, Inc. | 2004 | — |
| +1 | K061455 | Dornier Medilas H 20 Laser | Dornier Medtech America, Inc. | 2006 | — |
| +2 | K122159 | Dornier Medilas H30 Solvo | Dornier Medtech America, Inc. | 2013 | — |
| +3 | K180350 | Dornier Medilas H Solvo 35 Laser | Dornier Medtech America | 2018 | — |
| +2 | K130344 | Dornier Medilas Uropulse | Dornier Medtech America, Inc. | 2013 | — |
| +2 | K080525 | Cook Odyssey Holmium Laser System, Model 30W | Cook Urological, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 2 | 0 |
| 2018 | 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? (2)
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 OmniPulse-MAX laser system Named without a submission number | |
| * | — | Trimedyne OmniPulse Jr. laser system Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061455 | Dornier Medilas H 20 Laser | 2006 | 4 |
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, K061455 (Dornier Medtech America, Inc., 2006) has gone furthest, with 4 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. Dermatology 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. Dermatology 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; corns; periungual and subungual warts; papillomas; debridement of decubitus ulcer; skin tag vaporization
2. Gastroenterological/Gastrointestinal Surgery, including:
cholecystectomy; varices; lysis of adhesions; esophagitis; appendectomy; esophageal ulcer; biopsy; Mallory-Weiss tear; pylorostenotomy; gastric ulcer; benign and malignant lesions; duodenal ulcer; rectal polyps of sigmoid colon; non-bleeding ulcer; gall bladder calculi; gastric erosions; biliary/bile duct calculi; colorectal cancer; benign and malignant neoplasm; gastritis; polyps; bleeding tumors; colitis; pancreatitis; ulcers; vascular malformations; angiodysplasia; telangiectasias; hemorrhoids; telangiectasias of the Osler-Weber-Rendu disease
3. General Surgery of soft tissue, including:
skin incision; herniorrhaphy; tissue dissection; tonsillectomy; excision of external tumors and lesions; lymphadenectomy; complete or partial resection of internal organs; partial nephrectomy; tumors and lesions; pilonidal cystectomy; tissue ablation; resection of lipoma; mastectomy; pelvic adhesiolysis; hepatectomy; debridement of decubitus ulcer; pancreatectomy; hemorrhoids; splenectomy; pilonidal cyst removal and repair; thyroidectomy; debridement of stasis ulcer; parathyroidectomy; biopsy
4. Genitourinary Surgery/Urology, including:
superficial urinary bladder tumors; urethral and penile hemangioma; invasive bladder carcinoma; bladder neck obstructions; urethral strictures; holmium laser incision, excision, resection, ablation, hemostasis, vaporization, and enucleation in the treatment of benign prostatic hyperplasia (BPH); lesions of the external genitalia; bladder; urethral and ureteral tumors; condylomas
5. Gynecological Surgery 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; dacryocystorhinostomy (DCR); sphenoidotomy; ethmoidectomy
9. Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression / Discectomy: Superficial incision, excision, resection, ablation, coagulation, hemostasis and vaporization, with or without an endoscope, in the following:
Percutaneous Lumbar Disc Decompression/Discectomy 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, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms; 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/Discectomy in soft tissue, in patients with: uncomplicated ruptured or herniated discs; thoracic and intercostal intractable pain; paresthesia at levels appropriate to the herniated discs visualized on MRI and CT-myelography; MRI, CT, myelogram, or discogram findings of disc herniation consistent with patient signs and symptoms; 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 Trimedyne Side Firing Needle with Vent Sheath family of optical fiber delivery devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043012: Omnipulse Mini, Model 2120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043012
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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