OMNIPULSE/OMNIPULSE-MAX
K962632 · Trimedyne, Inc. · GEX · Jan 16, 1997 · General, Plastic Surgery
Device Facts
| Record ID | K962632 |
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| Device Name | OMNIPULSE/OMNIPULSE-MAX |
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| Applicant | Trimedyne, Inc. |
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| Product Code | GEX · General, Plastic Surgery |
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| Decision Date | Jan 16, 1997 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 878.4810 |
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| Device Class | Class 2 |
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| Attributes | Therapeutic |
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Intended Use
The laser systems are intended for use in multispecialty applications, including dermatology and plastic surgery, discectomy, general surgery, genitourinary surgery, lithotripsy, orthopedic surgery, endoscopic sinus surgery, and otorhinolaryngology. The fiber optic delivery systems are intended for use with any holmium laser (with a compatible connector) for its cleared applications.
Device Story
Class IV pulsed solid-state Ho:YAG laser systems (2.1 micron wavelength) and fiber optic delivery devices. Laser systems feature menu-driven controls for pulse repetition rate, output energy, and lasing duration. Delivery devices consist of flexible buffered optical fiber bundles in stainless steel shafts with SMA or custom connectors. Used by physicians in clinical/surgical settings for tissue ablation, incision, excision, and lithotripsy. Laser energy delivered via contact or near-contact fibers to target tissue. Integrated power meters on some models allow output verification. Benefits include precise tissue interaction and multispecialty surgical utility.
Clinical Evidence
No clinical data.
Technological Characteristics
Class IV pulsed Ho:YAG laser; 2.1 micron wavelength; 350 microsecond pulse width. Power output up to 100W/4200mJ/100pps. Delivery devices: multi-fiber bundle, stainless steel shaft, SMA/custom connectors. Sterilization: sterile/non-pyrogenic or user-sterilized. Biocompatible materials.
Indications for Use
Indicated for patients requiring surgical intervention in dermatology, plastic surgery, discectomy, general surgery, genitourinary surgery, lithotripsy, orthopedic surgery, endoscopic sinus surgery, and otorhinolaryngology.
Regulatory Classification
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
Predicate Devices
- Tissue Technologies, Inc. TRU-PULSE™ Pulsed CO₂ Surgical Laser System
- Coherent® UltraPulse® 5000C Aesthetic Laser System
- Trimedyne Optilase® 1000-100 Nd:YAG Laser
- Omni™ Switchtip System
- Tapertip™ Multiuse Holmium Arthroscopy Handpieces
Related Devices
- K041660 — TRIMEDYNE HOLMIUM LASER SYSTEMS · Trimedyne, Inc. · Sep 8, 2004
- K061455 — DORNIER MEDILAS H 20 LASER · Dornier Medtech America, Inc. · Aug 1, 2006
- K183563 — Holinwon 30 · Wontech Co., Ltd. · Sep 5, 2019
- K161257 — MultiPulse HoPLUS · Asclepion Laser Technologies GmbH · Mar 31, 2017
- K992574 — OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A · Trimedyne, Inc. · Oct 29, 1999
Submission Summary (Full Text)
{0}
JAN 16 1997
455
# Trimedyne
## K962632
# Summary of 510(k) Safety and Effectiveness Information
## Trimedyne® Holmium:YAG Laser Systems and Fiber Optic Delivery Devices for Multispecialty Applications
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
### I. Submitter Information:
Trimedyne, Inc.
P.O. Box 57001
Irvine, CA 92619-7001
714/559-5300
714/559-1330
Contact Person: Susan H. Gamble
Director, Regulatory Affairs & Quality Assurance
Summary Date: July 3, 1996
### II. Device Name
Proprietary: OmniPulse™ Holmium Laser (Model 1210)
OmniPulse-MAX™ Holmium Laser (Model 1210-VHP)
Not yet determined for Proposed Holmium Laser
Not yet determined for Proposed Delivery Systems
Common: Holmium:Yttrium Aluminum Garnet (Ho:YAG) laser system
Laser Fiber
Classification: Laser-powered instrument
Accessory to Laser-powered instrument
### III. Predicate Device
The predicate devices for the laser systems are the Tissue Technologies, Inc. TRU-PULSE™ Pulsed CO₂ Surgical Laser System, Coherent® UltraPulse® 5000C Aesthetic Laser System, and the Trimedyne Optilase® 1000-100 Nd:YAG Laser.
The predicate devices for the fiber optic delivery systems are the Omni™ Switchtip System and the Tapertip™ Multiuse Holmium Arthroscopy Handpieces, both of which are currently marketed by Trimedyne.
### IV. Device Description
The OmniPulse and OmniPulse-MAX Holmium Lasers are medical grade, Class IV, pulsed, solid-state, Ho:YAG laser systems designed to deliver pulsed infrared laser energy with a wavelength of 2.1 micron and 350 microsecond pulse width. Menu-driven control options allow the user to select pulse repetition rate, output energy, and maximum lasing period.
The Proposed Laser System is a medical grade, Class IV, pulsed, solid-state Ho:YAG laser system designed to deliver pulsed infrared laser energy with a wavelength of 2.1 micron. The pulsewidth may either be 350 microseconds or variable up to a maximum of 350 microseconds, depending on the configuration of the laser. Menu-driven control options allow the user to select pulse repetition rate, output energy, pulsewidth (if variable), and lasing duration.
TRIMEDYNE, INC.
2801 BARRANCA ROAD, IRVINE, CA 92714
F\USERSILE\FDA\510K\DERMPLUS HO\510K_SUB.DOC 3-Jul-94 559-5300, FAX 714 559-1330
800 733-5273
{1}
The proposed delivery systems are single use, contact or near-contact fiber optic energy delivery devices consisting of a flexible bundle of buffered optical fibers contained in a stainless steel shaft; the proximal end of the laser fiber optic incorporates either a custom or a SMA connector. These devices are shipping sterile/non-pyrogenic: from time-to-time they may be offered in non-sterile form in which case the user will be provided with sterilization instructions.
## V. Intended Use
The laser systems are intended for use in multispecialty applications, including dermatology and plastic surgery, discectomy, general surgery, genitourinary surgery, lithotripsy, orthopedic surgery, endoscopic sinus surgery, and otorhinolaryngology.
The fiber optic delivery systems are intended for use with any holmium laser (with a compatible connector) for its cleared applications.
## VI. Technological Characteristics
The Trimedyne laser systems included in this submission are Holmium:YAG lasers which emit light at a wavelength of 2.1 microns (near infrared) and a maximum pulse width of 350 microseconds.
The OmniPulse has the capability of attaining a maximum output of 40 watts of power (maximum 40 watts/3500 mJ and maximum frequency mode of 25 pps).
The OmniPulse-MAX has the capability of attaining a maximum output 80 watts of power (maximum 80 watts/3500 mJ and maximum frequency mode of 60 pps). This laser can operate in either single- or double-pulse mode and has an integrated power meter to enable the user to easily measure the output power.
The Proposed Laser System has the capability of attaining a maximum output of 100 watts of power (maximum 100 watts/4200 mJ and maximum frequency mode of 100 pps).
The proposed delivery devices differ from their predicate devices in that they are designed with multiple fibers, as opposed to a single-fiber configuration.
## VII. Nonclinical Tests
The proposed delivery systems were subjected to a series of tests; these tests included sterilization, efficiency, performance and mechanical studies. Biocompatibility data exhibiting the acceptability of materials used in the fiber optic delivery systems was also submitted.
## VIII. Clinical Tests
No clinical tests were submitted in this 510(k).
## IX. Conclusions Drawn from Testing
The proposed delivery systems are biocompatible and exhibit acceptable performance and mechanical properties when used according to their labeling.
A\USERS\LEVDA\510K\DERMPLUS HO\510K_SUB.DOC 3 Jul 96
