LAZRPULSR 4X

K041565 · Led Healing Light, LLC · NHN · Mar 3, 2005 · Physical Medicine

Device Facts

• Record ID: K041565
• Device Name: LAZRPULSR 4X
• Applicant: Led Healing Light, LLC
• Product Code: NHN · Physical Medicine
• Decision Date: Mar 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lazr Pulsr 4x is a non-heating lamp, infrared as described under the provisions of 21 CFR 890.5500 and is indicated for: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Device Story

The Lazr Pulsr 4x is an infrared lamp device used for the temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin. It functions as a non-heating infrared lamp. The device is intended for prescription use. It provides adjunctive therapy to assist in pain management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infrared lamp; non-heating; classified under 21 CFR 890.5500; product code NHN.

Indications for Use

Indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border of the circle. Inside the circle is a symbol that resembles an eagle with three stylized wings.

Public Health Service

MAR 3 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael B. Kinder Chief Executive Officer LED Healing Light, LLC 7487 S. Glencoe Court Centennial, Colorado 80122

Re: K041565

Trade/Device Name: Lazr Pulsr 4x Regulation Number: 21 CFR 890.5500 Regulation Name: Infrarcd lamp Regulatory Class: II Product Code: NHN Dated: January 27, 2005 Received: February 15, 2005

Dear Mr. Kinder:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bection 310(s) peace is substantially equivalent (for the indications felerenced above and nave actering marketed predicate devices marketed in interstate for use stated in the enclosure) to regars and the Medical Device Amendments, or to commerce prior to may 20, 1978, the accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic 7cc (71ct) that do nov col subject to the general controls provisions of the Act. The r ou may, mercione, mance 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 If your device is olassified (600 as . ) , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , ' , , ' , , , , , , may be subject to suen adonal egulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obao neements 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 that 1177 than matures and regulations administered by other Federal agencies. You must or any I cacal stutures and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set er A rate 6077, accems (QS) regulation (21 CFR Part 820); and if applicable. the electronic form in the quarty byevel provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Michael B. Kinder

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in yours of substantial equivalence of your device to a legally prematics notification " ritesults 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 11 you active 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 other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Miriam C. Provost

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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## D Updated Indications For Use

510(k) Number: K 041565

## Device Name: Lazr Pulsr 4x

## Indications for Use:

The Lazr Pulsr 4x is a non-heating lamp, infrared as described under the provisions of 21 CFR 890.5500 and is indicated for:

Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

or

Prescription Use _x_ (Per CFR 801.109)

Over-the-counter use _________________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE)

uriam C. Provost

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________