510(k) Report

510(k) · Cleared

Cleared

Omnipulse Mini, Model 2120

K043012510(k) TraditionalCleared Nov 17, 200415-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Descendants, by year cleared 2006: 1 descendant cleared2013: 2 descendants cleared2008: 1 descendant cleared2018: 1 descendant cleared200020052010201520202025
  1. This deviceK043012 Omnipulse Mini, Model 2120Trimedyne, Inc. · 2004
  2. Descendant · cites it directly · 4 of its ownK061455 Dornier Medilas H 20 LaserDornier Medtech America, Inc. · 2006
  3. Descendant · 2 generations on · 2 of its ownK122159 Dornier Medilas H30 SolvoDornier Medtech America, Inc. · 2013
  4. Descendant · 3 generations on · 0 of its ownK180350 Dornier Medilas H Solvo 35 LaserDornier Medtech America · 2018
  5. Descendant · 2 generations on · 0 of its ownK130344 Dornier Medilas UropulseDornier Medtech America, Inc. · 2013
  6. 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K043012Omnipulse Mini, Model 2120Trimedyne, Inc.2004—
+1K061455Dornier Medilas H 20 LaserDornier Medtech America, Inc.2006—
+2K122159Dornier Medilas H30 SolvoDornier Medtech America, Inc.2013—
+3K180350Dornier Medilas H Solvo 35 LaserDornier Medtech America2018—
+2K130344Dornier Medilas UropulseDornier Medtech America, Inc.2013—
+2K080525Cook Odyssey Holmium Laser System, Model 30WCook Urological, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
201320
201810
FIG. 1 — Lineage of K043012, 2004–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—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.

NumberDeviceApplicantDecidedDescendants
K061455Dornier Medilas H 20 LaserDornier Medtech America, Inc.20064

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 devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

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.

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