(65 days)
The MLT Erbium: YAG Laser System device is designed specificially for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology.
The Medical Laser Technologies, LLC MLT Erbium: YAG Laser System is an Er: YAG laser producing emission at a wavelength of 2940 nm. The laser consist of two interconnected sections: The cabinet which houses the power supply, the cooling system and the electronics, and; the umbilical cables and the hand piece, which houses the laser.
The provided text is a 510(k) summary for the Medical Laser Technologies, LLC MLT Erbium: YAG Laser System. It focuses on the device description, intended use, and substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data.
Therefore, I cannot extract the information required to fill out a table of acceptance criteria and device performance, nor can I answer questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document does not contain information on acceptance criteria or a study that proves the device meets those criteria.
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OCT 2 9 2003
K032599 1 of 2
Attachment I
510(K) Summary Medical Laser Technologies, LLC MLT Erbium: YAG Laser System
This 510(K) Summary of safety and effectiveness for the MLT Erbium: YAG Laser System is submitted in accordance with the requirements of SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Medical Laser Technologies, LLC |
|---|---|
| Address: | 516 Scott StreetHomewood, AL 35209 |
| Contact Person: | Mark Rohrer, Managing Member |
| Telephone:Telefax: | 205-290-8251205-290-4269 |
| Preparation Date: | July 1, 2003 |
| Device Trade Name:System | Medical Laser Technologies, LLC, MLT Erbium: YAG Laser |
| Common Name: | Erbium: YAG laser devise |
| Classification Name: | Instrument, Powered, Laser79-GEX21 CFR 878-48 |
| Legally Marketed PredicateDevice | Schwartz Electro-Optics TriLase 2940, K#954013Cell Robotics Er:YAG Laser System, K#970461Asceplion-Meditec Dermastar Er:YAG Laser System, K#014057 |
| Description of the Device | The Medical Laser Technologies, LLC MLT Erbium: YAG LaserSystem is an Er: YAG laser producing emission at awavelength of 2940 nm. The laser consist of twointerconnected sections: The cabinet which houses thepower supply, the cooling system and the electronics, and;the umbilical cables and the hand piece, which houses thelaser. |
| Intended Use of the Device: | The MLT Erbium: YAG Laser System device is designedspecifically for superficial skin ablation resulting in skindermabrasion, and the treatment of wrinkles. In addition thissystem is intended for coagulation, vaporization, ablation, orcutting of soft tissue (skin) in dermatology, plastic surgery(including aesthetic surgery), oral surgery, and ophthalmology. |
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K032599 2 of 2
INTRODUCTION
The Medical Laser Technologies, LLC MLT Erbium: YAG Laser System is intended for superficial skin ablation resulting in skin dermabrasion and the treatment of wrinkles. In addition, the system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery, (including aesthetic surgery), oral surgery and opthalmology. The laser system is designed for reliability, for long life, and ease of use. As a result, no maintenance should be required other than cleaning the instrument and an annual calibration check.
As with any laser system, appropriate care must be taken to ensure proper and safe use. This entire manual should be thoroughly reviewed before operating the instrument. Further, the physician should attend a certified laser-training course before using the Medical Laser Technologies, LLC MLT Erbium: YAG Laser System for medical treatment.
All users should become familiar with the requirements for safe use of medical laser systems as described in the American National Standards Institute (ANSI) publications, American National Standard for the Safe Use of Lasers in Health Care Facilities (ANSI Z126.3-1988), AND, American National Standard for the Safe Use of lasers (ANSI Z136.1-1986). The information in this manual is provided in accordance with these Standards.
Chapter 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three flowing lines representing the body and head.
Public Health Service
OCT 2 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mark Rohrer Managing Member Medical Laser Technologies, LLC 516 Scott Street Homewood, Alabama 35209
Re: K032599
Trade/Device Name: Medical Laser Technologies, LLC MLT Erbium: YAG Laser System 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: July 7, 2003 Received: August 27, 2003
Dear Mr. Rohrer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Insting 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 be found 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 comply 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Mark Rohrer
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Fo 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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INDICATION FOR USE STATEMENT
510(K) Number: K032599
Device Name: Medical Laser Technologies, LLC MLT Erbium: YAG Laser System
Indications for Use:
The MLT Erbium: YAG Laser System device is designed specificially for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology.
(Please do not write below this line - continue on another page if needed)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices '
510(k) Number K032599
Concurrence of CDRH, Office of Device Evaluation (OD
Prescription Use
(per 21 CFR 801.109) OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.