(153 days)
Not Found
Not Found
No
The provided 510(k) summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses solely on the intended use as an adjunct to liposuction for pain reduction.
Yes
The device is indicated for the reduction of pain associated with the recovery process after liposuction, which is a therapeutic purpose.
No
The device is indicated as an adjunct to liposuction procedures for pain reduction, not for diagnosing any condition or disease.
No
The provided 510(k) summary does not contain enough information to determine if the device is software-only. The "Device Description" section is missing, which is crucial for understanding the device's components and whether it includes hardware. The intended use as an adjunct to liposuction suggests a potential interaction with a physical procedure, further indicating the need for a device description to clarify its nature.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an adjunct to liposuction procedures of the hips and stomach for reduction of pain associated with the recovery process." This describes a therapeutic or adjunctive treatment applied to the body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The device appears to be a therapeutic device used externally on the patient's body.
N/A
Intended Use / Indications for Use
The Erchonia EML is indicated as an adjunct to liposuction procedures for the temporary reduction of pain associated with the recovery process.
Product codes
NHN
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hips and stomach
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
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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_________________________________________________________________________________________________________________________________________________________________