LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM

K041419 · Medical Energy, Inc. · GEX · Aug 26, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041419
• Device Name: LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM
• Applicant: Medical Energy, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LIGHTFORCE 20/30 980mm Diode Surgical Laser is intended to provide the physician with a dependable laser system providing he/she the ability to incise, excise, vaporize and coagulate soft tissue in a variety of surgical procedures in various disciplines as listed: Dermatology ENT/Head & Neck Gynecology Gastroenterology General Surgery Neurosurgery Pulmonary Urology Proctology

Device Story

LIGHTFORCE 20/30 980nm Diode Surgical Laser system; utilizes diode laser energy for soft tissue surgery. Physician-operated in clinical/surgical settings; compatible with standard endoscopes. System uses disposable fiber optic delivery systems (200, 400, 600, 1000 micron sizes) for contact or non-contact techniques. Laser energy enables incision, excision, vaporization, and coagulation of soft tissue at controllable depths (0.3mm to 4mm). Device provides surgical precision for various medical specialties; assists physicians in managing tissue during open or endoscopic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

980nm diode laser surgical system. Energy source: diode laser. Delivery: disposable fiber optic systems (200-1000 micron). Operation: contact and non-contact modes. Depth control: 0.3mm to 4mm. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for soft tissue incision, excision, vaporization, and coagulation in gastroenterology, general surgery, gynecology, ENT/head & neck, neurology, urology, pulmonary, and plastic surgery. Specific applications include endometrial ablation, urology surgery, rectal pathology/hemorrhoids, GI bleeding, palliation of GI malignancies, and pulmonary obstructions.

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

• Gynecology-Endometrial Ablation (K871512)
• Urology Surgery (K871516)
• Rectal Patho. & Hemorrhoid (K871514)
• Gastro Intestinal Bleeding (K871515)
• Palliation of Gastro Malignancies (K871513)
• Pulmonary Obstructions (K871511A)

Submission Summary (Full Text)

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K04/419

AUG 2 6 2004

## 510 K General Summary

The LIGHTFORCE 20/30 980mm Diode Surgical Laser is intended to provide the physician with a dependable laser system providing he/she the ability to incise, excise, vaporize and coagulate soft tissue in a variety of surgical procedures in various disciplines as listed:

Dermatology ENT/Head & Neck Gynecology

Gastroenterology General Surgery Neurosurgery

Pulmonary Urology Proctology

The LIGHTFORCE 20/30 980mm Diode Surgical Laser for soft tissue applications is accompanied by a variety of disposable fiber optic delivery systems for use in the different specialties. Each are compatible to all popular endoscopes on the market. A variety of Disposable Fiber Optic Delivery Systems are available for performing open and endoscopic surgical procedures with the LIGHTFORCE 20/30 980mm Diode Surgical Laser System for achieving incision, excision, vaporization and coagulation on soft tissue applications.

These disposable fiber optic delivery systems are available in various sizes (200, 400, 600, and 1000 micron) for performing contact and non-contact laser surgery techniques by the operating physician to assist in achieving Incision/Excision/Vaporization/Coagulation at CONTROLLABLE depths of tissue penetration from 0.3mm up to 4mm.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 2004

Mr. David P. Lewing Director of Regulatory Affairs Medical Energy, Inc. 225 E. Zaragoza Street Pensacola, Florida 32502

Re: K041419

Trade/Device Name: LIGHTFORCE 20/30 980nm Diode Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: May 25, 2004 Received: May 28, 2004

Dear Mr. Lewing:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreated 776 the enactment date of the Medical Device Amendments, or to conimeres prior to may 20, 1978) ... . ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ................................................................... and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and coometer for ( 10) read the device, subject to the general controls provisions of the Act. The r ou may, dierefore, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may or sations in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Crth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty byrovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. David P. Lewing

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and my of your finding of substantial equivalence of your device to a legally promative noticated in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Mellman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(K) Number: K041419

LIGHTFORCE 20/30 980nm Diode Laser Device Name:

Indications For Use:

- For soft tissue Incision, Excision, Vaporization and Coagulation: 1.
- * Gastroenterology
- * General Surgery
- * Gynecology
- * ENT/Head & Neck
- * Neurology
- * Urology
- * Pulmonary
- * Plastic Surgery

## Including:

- * Gynecology-Endometrial Ablation (K871512)
- * Urology Surgery (K871516)
- * Rectal Patho. & Hemorrhoid (K871514)
- * Gastro Intestinal Bleeding (K871515)
- * Palliation of Gastro Malignancies (K871513)
- * Pulmonary Obstructions (K871511A)

| Prescription Use _____________________________________________________________________________________________________________________________________________________________ | AND/OR | Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

**510(k) Number** K041419