← Product Code [NHN](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN) · K041565 # LAZRPULSR 4X (K041565) _Led Healing Light, LLC · NHN · Mar 3, 2005 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K041565 ## Device Facts - **Applicant:** Led Healing Light, LLC - **Product Code:** [NHN](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN.md) - **Decision Date:** Mar 3, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.5500 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## 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. ## 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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. {1}------------------------------------------------ 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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 {2}------------------------------------------------ ## 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_________________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K041565](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K041565) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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