# K043012: Omnipulse Mini, Model 2120

- Pathway: 510(k) (Traditional)
- Applicant: Trimedyne, Inc.
- Decided: Nov 17, 2004 after 15 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 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 OmniPulse-MAX laser system: named in the summary without a submission number
- (no number) Trimedyne OmniPulse Jr. laser system: named in the summary without a submission number

## Most influential descendants
- K061455: Dornier Medilas H 20 Laser (2006), 4 descendants of its own
- K122159: Dornier Medilas H30 Solvo (2013), 2 descendants of its own
- K180350: Dornier Medilas H Solvo 35 Laser (2018), 0 descendants of its own
- K130344: Dornier Medilas Uropulse (2013), 0 descendants of its own
- K080525: Cook Odyssey Holmium Laser System, Model 30W (2008), 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. 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.

Source page: https://510kreport.com/device/K043012
Methodology: https://510kreport.com/methodology