The Neurolase™ devices are an infrared lamp per 21 CFR 890.5500 that emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature to provide temporary relief of minor muscles and joint pain and stiffness, minor pain and stiffness associated with arthritis, or muscle spasm. These devices may temporarily increase blood circulation, and may be used to promote relaxation of muscle tissue.

Device Description

The Neurolase™ devices consist of a control unit and a handpiece The control unit houses the power supply, control electronics, calibration port, and infrared radiation source. The source is coupled to a fiber optic cable that delivers the energy to the patient through the handpiece.

AI/ML Overview

The provided text does not describe acceptance criteria, nor does it detail a study performed to prove a device meets acceptance criteria for the Neurolase™ Series device.

Instead, this document is a 510(k) pre-market notification summary for the Neurolase™ Series device, outlining its substantial equivalence to previously marketed infrared lamps.

Here's a breakdown of what the document does state regarding testing and performance, and why it doesn't fit the requested criteria:

Performance Data Section (Section 6, Page 1 of 2):

"The differences in the specifications of the Neurolase™ devices and the predicate devices result in enhanced performance for the Neurolase™ devices and do not raise new questions of safety or efficacy."
- Comment: This statement claims enhanced performance but provides no specific metrics, acceptance criteria, or study results to back this up. It's a general assertion rather than a demonstration of meeting predefined criteria.

Testing Section (Section 7, Page 2 of 2):

"Prototype units have undergone preliminary testing to ensure compliance with UL2601 and FCC Part 15 requirements."
- Comment: This refers to preliminary testing for electrical safety and electromagnetic compatibility standards, not performance or clinical efficacy against specific acceptance criteria for its intended use (pain relief, increased blood circulation).
"Once marketing clearance is granted, safety and emissions testing will take place at a registered body."
- Comment: This indicates future testing for safety and emissions, again not performance against acceptance criteria for its therapeutic claims.
"Production units will each be run through an Acceptance Test Procedure to ensure compliance with the System Specification."
- Comment: This mentions an "Acceptance Test Procedure" and "System Specification" for production units, implying internal quality control checks. However, the document does not provide the specific acceptance criteria defined in this System Specification, nor does it present the results of such a procedure or a study proving compliance.
"All components have been chosen to ensure compliance with the aforementioned standards."
- Comment: This is a statement about component selection, not a study or performance data.

Conclusion:

The submission focuses entirely on establishing substantial equivalence to predicate devices based on intended use and general device characteristics. It explicitly states that "The differences in the specifications...do not raise new questions of safety or efficacy," implying that extensive new performance studies beyond basic safety/emissions compliance were not deemed necessary for this 510(k) clearance.

Therefore, since the document does not contain the requested information, the table and other points cannot be filled out as requested.

Summary

{0}------------------------------------------------

NOV 2 0 2003

K032787 1 of 2

Section 6. 510(K) Pre-Market Notification Summary of Safety and Effectiveness

1. Submitter's Name and Address

Spectrum Laser & Technologies, Inc. 4980A Centennial Blvd. Colorado Springs, CO 80919 Phone: (719) 264-7632 Fax: (719) 548-8289

Key Contact: Thomas R. Radebaugh

Date Prepared: 8/26/2003

2. Device Name

Proprietary Name: Neurolase™ Series Common / Usual Name: Infrared Lamp Classification Name: Infrared Lamp (21 CFR 890.5500) Product Code: ILY

3. Legally-Marketed Predicate Devices

The Neurolase™ devices are substantially equivalent to other infrared sources currently in commercial distribution such as the Super NovalAcubeam systems (K001179) manufactured by Light ForceTherapy, Inc., the Medx 1000 Series devices (K020017) manufactured by Medx Health Corporation, the Photonic Stimulator (K974468) manufactured by Bales Scientific, the SLP 1000 Thermapulse (K024179) manufactured by Palomar, the Pain-X 2000 (K982546) manufactured by Diomedics, and the SLP 1000 Thermapulse (K024179) manufactured by Palomar.

4. Intended Use of the Device

The Neurolase™ devices emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. These devices may temporarily increase blood circulation, and may be used to promote relaxation of muscle tissue.

5. Description of the Device

6. Performance Data

The differences in the specifications of the Neurolase™ devices and the predicate devices result in enhanced performance for the Neurolase™ devices and do not raise new questions of safety or efficacy.

{1}------------------------------------------------

K032787 2 of 2

7. Testing

Prototype units have undergone preliminary testing to ensure compliance with UL2601 and FCC Part 15 requirements. Once marketing clearance is granted, safety and emissions testing will take place at a registered body. Production units will each be run through an Acceptance Test Procedure to ensure compliance with the System Specification. All components have been chosen to ensure compliance with the aforementioned standards.

8. Conclusion

Based on the foregoing, the Neurolase™ Series is substantially equivalent to the legally-marketed predicate devices.

{2}------------------------------------------------

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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines above them.

Public Health Service

NOV 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas R. Radebaugh Vice President of Engineering Spectrum Laser & Technologies, Inc. 4980A Centennial Boulevard Colorado Springs, Colorado 80919

Re: K032787

Trade/Device Name: Neurolase™ Series Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: September 2, 2003 Received: September 9, 2003

Dear Mr. Radebaugh:

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. Drue. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM ). 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. Iisting 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.

{3}------------------------------------------------

Page 2 - Mr. Thomas R. Radebaugh

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

for 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

{4}------------------------------------------------

Section 4. Statement of Indications for Use

Indication for Use

510(k) Number: K032787

Device Name: Neurolase™ Series

Indications for Use:

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K032787

Page 4-1

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.