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Found 15 results
510(k) Data Aggregation
K Number
K053457Device Name
VAPORMAX II
Manufacturer
TRIMEDYNE, INC.
Date Cleared
2005-12-21
(8 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TRIMEDYNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VAPORMAX II is intended for surgical use including: incision, vaporization, vaporization, in ablation, and coagulation of soft tissue.
The VAPORMAX II is indicated for use with any cleared Holmium:YAG 2.1 micrometer laser with a compatible connector for that laser's cleared indications for use.
Device Description
The VAPORMAX II is a single use, disposable, side firing, fiber optic energy delivery device for use with cleared Holmium:YAG lasers.
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K Number
K050412Device Name
VAPORMAX
Manufacturer
TRIMEDYNE, INC.
Date Cleared
2005-03-14
(24 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TRIMEDYNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VAPORMAX is intended for surgical use including: incision, excision, vaporization, ablation, and coagulation of soft tissue.
The VAPORMAX is indicated for use with any cleared Holmium:YAG 2.1 micrometer laser with a compatible connector for that laser's cleared indications for use.
Device Description
The VAPORMAX is a single use, disposable, side firing, fiber optic energy delivery device for use with cleared Holmium:YAG lasers.
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K Number
K043012Device Name
OMNIPULSE MINI, MODEL 2120
Manufacturer
TRIMEDYNE, INC.
Date Cleared
2004-11-17
(15 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TRIMEDYNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Superficial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:
- Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures
- Gastroenterological/Gastrointestinal Surgery
- General Surgery of soft tissue
- Genitourinary Surgery/Urology
- Gynecological Surgery during open and endoscopic procedures
- Lithotripsy and Percutaneous Urinary Lithotripsy
- Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints
- Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue
- Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression / Discectomy
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.
Device Description
The OmniPulse" Mini Laser System Model 2120 is a pulsed solid-state Holmium:YAG laser system is designed to deliver infrared laser energy with a wavelength of 2.1 um and a nominal pulse width of 350 microseconds. Menu driven control options allow the operator to select the pulse energy, the pulse repetition rate or frequency, and one of three exposure modes (continuous, single burst or repetitive burst).
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K Number
K041660Device Name
TRIMEDYNE HOLMIUM LASER SYSTEMS
Manufacturer
TRIMEDYNE, INC.
Date Cleared
2004-09-08
(82 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TRIMEDYNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasia [facial, leg], and rosacea), COLIS, papillomas, basal cell carcinomas, lesions of skin and subcutaneous tissue, plantar warts, periungual and subungual warts, debridement of decubitus ulcer, 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, complete or partial resection of internal organs, tumors and lesions, tissue ablation, mastectomy, hepatectomy, pancreatectomy, splenectomy, thyroidectomy, parathyroidectomy, hemiorrhaphy, tonsillectomy, lymphadenectomy, partial nephrectomy, pilonidal cystectomy, resection of lipoma, pelvic adhesiolysis, debridement of decubitus ulcer, hemorrhoids, pilodidal cyst removal and repair, debridement of statis ulcer, biopsy
4. Genitourinary Surgery/Urology, including: superficial urinary bladder tumors, invasive 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 prostatic hyperplasia (BPH)
5. Gynecological Surgery during open and endoscopic procedures, including: condyloma acuminata
6. Lithotripsy and Percutaneous Urinary Lithotripsy, including: fragmentation of urinary calculi, fragmentation of urethral calculi, fragmentation of kidney 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, knee synovectomy, chondromalacia and tears, loose body debridement, lateral retinacular release, debridement of the degenerative knee, plica removal, ligament and tendon release, contouring and sculpting of articular surfaces, debridement of inflamed synovial tissue, capsulectomy in the knee, chondroplasty in the knee, chondromalacia ablation
8. Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g., turbinectorny), dacryocystorhinostomy (DCR), ethmoidectomy, polypectomy, maxillary antrostomy, frontal sinusotomy, sphenoidotomy
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/Discectorny in soft, cartilaginous, and bony tissue, including: foraminoplasty; Percutaneous Cervical Disc Decompression/Discectorny 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/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 MRI and CT-myclography, 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; interstital applications should only be performed using the Trimedyne Side Firing Needle with Vent Sheath family of optical fiber delivery devices.
Device Description
The Trimedyne Holmium Laser System is a medical grade, Class IV, pulsed, solid state Holmium: YAG laser system designed to deliver pulsed infrared laser energy with a wavelength of 2.1 um and 350 microseconds pulsewidth. Menu-driven control options allow the users to select pulse repetition rate, output energy, and lasing duration.
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K Number
K022655Device Name
TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH
Manufacturer
TRIMEDYNE, INC.
Date Cleared
2002-11-07
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TRIMEDYNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Superficial and interstitial incision, excision, ablation, vaporization, and coagulation.
Device Description
The Side Firing Needle with Vent Sheath is a single use, disposable fiberoptic energy delivery device for use with the Omni™ Multiuse Handpiece and Fiber Assembly. The device consists of a near-contact laser fiber enclosed in a stainless steel pointed needle assembly. The device includes a luer connector assembly that connects the irrigation channel to an irrigation fluid source via an external line, as well as a vent sheath with proximal exhaust ports that terminates just proximal to the beam exit point. The Side Firing Needle with Vent Sheath is attached to the Omni Multiuse Handpiece through a quick-connect mechanism.
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K Number
K013974Device Name
RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A
Manufacturer
TRIMEDYNE, INC.
Date Cleared
2002-09-23
(294 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TRIMEDYNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:
- 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; Paresthesias 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)
Device Description
The Trimedyne Holmium Laser System is a medical grade, Class IV, pulsed, solid state Holmium:YAG laser system designed to deliver pulsed infrared laser enerqy with a wavelength of 2.1 µm and 350 microseconds pulsewidth. Menu-driven control options allow the users to select pulse repetition rate, output energy, and lasing duration.
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K Number
K002308Device Name
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A
Manufacturer
TRIMEDYNE, INC.
Date Cleared
2000-12-20
(145 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TRIMEDYNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001676Device Name
OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A
Manufacturer
TRIMEDYNE, INC.
Date Cleared
2000-11-02
(154 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TRIMEDYNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992574Device Name
OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A
Manufacturer
TRIMEDYNE, INC.
Date Cleared
1999-10-29
(88 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TRIMEDYNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Incision, excision, resection, ablation, vaporization, coagulation, and hemostasis in multispecialty applications, including dermatology and plastic surgery, discectomy, gastroenterological/ gastrointestinal surgery, general surgery, genitourinary surgery, lithotripsy, orthopedic surgery, endoscopic sinus surgery, and otorhinolaryngology surgery.
Device Description
The Trimedyne Holmium Laser System is a medical grade, Class IV, pulsed, solid state Holmium: YAG laser system designed to deliver pulsed infrared laser energy with a wavelength of 2.1 um and up to 350 microseconds pulsewidth. Menu-driven control options allow the users to select pulse repetition rate, output energy, and lasing duration.
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K Number
K992230Device Name
OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP
Manufacturer
TRIMEDYNE, INC.
Date Cleared
1999-07-12
(10 days)
Product Code
GEX, GBX, GCX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TRIMEDYNE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OmniTip™ Side Firing Switchable Tip with Suction/Irrigation is intended for use with any pulsed Holmium: YAG 2.1 micrometer laser with a compatible connector for incision, excision, ablation, vaporization, and coagulation.
Device Description
The OmniTip Side Firing Switchable Tip with Suction/Irrigation is a fiber optic energy delivery device consisting of a near-contact laser fiber enclosed in a needle assembly of a capillary tube and an external stainless steel shaft. The device is attached to the Omni Multiuse Handpiece through a quick-connect mechanism. A luer connector assembly installed at the proximal end of the device connects the suction/irrigation channel to a pump via an external line.
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