← Product Code [NHN](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN) · K041139 # ERCHONIA EML LASER (K041139) _Erchonia Medical, Inc. · NHN · Sep 30, 2004 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K041139 ## Device Facts - **Applicant:** Erchonia Medical, Inc. - **Product Code:** [NHN](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN.md) - **Decision Date:** Sep 30, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.5500 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## Indications for Use The Erchonia EML is indicated as an adjunct to liposuction procedures of the hips and stomach for reduction of pain associated with the recovery process. ## Device Story Erchonia EML Laser is a low-level laser device used as an adjunct to liposuction procedures. It is applied to the hips and stomach area to reduce pain associated with the post-operative recovery process. The device is operated by a clinician in a clinical setting. It functions by delivering laser energy to the target area to assist in pain management following surgery. ## Clinical Evidence No clinical data provided in the document. ## Technological Characteristics Infrared lamp (21 CFR 890.5500); Class II device; laser-based energy source. ## 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}------------------------------------------------ Public Health Service Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of an eagle. SEP 3 0 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Erchonia Medical, Inc. c/o Mr. Kevin Walls, RAC Regulatory Insight, Inc. 13 Red Fox Lanc Littleton, Colorado 80127 Re: K041139 Trade/Device Name: Erchonia EML Laser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: NHN Dated: August 2, 2004 Received: August 4, 2004 Dear Mr. Walls: 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration. 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. {1}------------------------------------------------ Page 2 - Mr. Kevin Walls, RAC This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow your o ogli maing of substantial equivalence of your device to a legally promatice notificated." The 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 in you active 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 goterers, 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 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}------------------------------------------------ Page 1 of 1 510(k) Number (if known): K041139 Device Name: Erchonia EML Laser Indications for Use: The Erchonia EML is indicated as an adjunct to liposuction mateations for of other hips and stomach for reduction of pain associated with the recovery process. Prescription Use X (Per 21 CFR 801.109) PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Muriane C. Provost (Div ision Sign-Off Division of General, Restorative, and Neurological Devices (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number __ 510(k) Number_________________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K041139](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NHN/K041139) **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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