(90 days)
No
The summary describes a low-level laser system with predefined protocols and user-defined settings for frequency and time. There is no mention of the device learning from data, adapting its behavior based on input, or using algorithms typically associated with AI/ML for diagnosis, treatment planning, or image analysis. The software mentioned appears to be for controlling the user interface and basic device functions.
Yes
The device is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin, and to treat moderate inflammatory Acne Vulgaris, which are therapeutic applications.
No
Explanation: The device is a low-level laser system intended for therapeutic purposes such as temporary pain relief and treating dermatological conditions, not for diagnosing medical conditions.
No
The device description explicitly details hardware components including laser diodes, a hand-held control device, a docking station, an internal battery, an inductive charging base, a power supply, and a touch screen. While it contains software, it is integral to the operation of the physical laser system.
Based on the provided text, the Erchonia® EVRL laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The intended uses are for providing temporary relief of minor chronic neck and shoulder pain and treating moderate inflammatory Acne Vulgaris. These are therapeutic applications on the human body, not diagnostic tests performed on samples taken from the body.
- Device Description: The device is described as a low-level laser system applied externally to the patient. It uses light to interact with tissue, not to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, preparing, or analyzing biological samples (like blood, urine, tissue, etc.) for diagnostic purposes.
Therefore, the Erchonia® EVRL laser is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Erchonia® EVRL laser is generally indicated:
a. while using the red and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,
b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.
Product codes (comma separated list FDA assigned to the subject device)
NHN, GEX
Device Description
The Erchonia® EVRL (Model# EVRL) is a low-level laser system that uses two semi-conductor diodes (visible red and violet light), red: 630-650 nm and violet: 380-450 nm. The Erchonia® EVRL (Model# EVRL) is a variable hertz device. The variable hertz feature of the Erchonia® EVRL (Model# EVRL) is a pulsed wave, defined as containing a selected series of breaks, variances. The Erchonia® EVRL (Model# EVRL) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 laser.
The Erchonia® EVRL (Model# EVRL) is indicated for use:
a. while using the red and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,
b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.
The Erchonia® Laser is applied externally and has proven through clinical trials to treat neck and shoulder pain with the red diode.
The components of the device consist of:
An ultra-slim hand-held battery-operated control device with a docking station providing two laser diodes a 640 nanometer and a 405 nanometer. Each laser diode emits its wavelength with a tolerance of ±10 nanometer. The lasers are powered by an internal battery that is recharged using a separate inductive charging base powered by an external class II medical power supply. This configuration offers portability as well as consistency of power.
The internal battery powers the two specially created and patented electronic diodes with an output of 7.5mW ± 1mW red and
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol that represents the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
Erchonia Corporation Steven Shanks President 650 Atlantis Road Melbourne, Florida 32904
August 8, 2019
Re: K191257
Trade/Device Name: Erchonia EVRL Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: NHN, GEX Dated: May 8, 2019 Received: May 10, 2019
Dear Steven Shanks:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Neil R.P. Ogden, M.S. Acting Team Assistant Director Light Based Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K191257
Device Name Erchonia® EVRL
Indications for Use (Describe)
The Erchonia® EVRL laser is generally indicated:
a. while using the red and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,
b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Owner Information
Name and Address of Sponsor / Manufacturer
Erchonia Corporation 650 Atlantis Rd. Melbourne, FL 32904 Telephone: 321-473-1251 Fax: 321-473-1608
Establishment Registration Number 2032513
Name and Address of Official Correspondent
Erchonia Corporation 650 Atlantis Rd. Melbourne, FL 32904 Contact: Mr. Steven Shanks Telephone: 321-473-1251 Fax: 321-473-1608 Email: sshanks@erchonia.com
Date Prepared
05/08/2019
Device Information
Trade Name: Erchonia® EVRL Model#: EVRL Common Name: Infrared Lamp Classification Name: Powered Light-Based Laser Non-Thermal Instrument with Non-Heating Effect for Adjunctive Use in Pain Therapy (21 CFR 890.5500) Classification: Class II Panel: Physical Medicine Product Code: NHN, GEX
Predicate Device
The Erchonia® EVRL (Model# EVRL) is substantially equivalent to the following predicate device: Erchonia® EVRL (Model# EVRL) K152196
The Erchonia® EVRL is the same model as the Erchonia® EVRL previously submitted under K152196.
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Device Description
The Erchonia® EVRL (Model# EVRL) is a low-level laser system that uses two semi-conductor diodes (visible red and violet light), red: 630-650 nm and violet: 380-450 nm. The Erchonia® EVRL (Model# EVRL) is a variable hertz device. The variable hertz feature of the Erchonia® EVRL (Model# EVRL) is a pulsed wave, defined as containing a selected series of breaks, variances. The Erchonia® EVRL (Model# EVRL) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 laser.
The Erchonia® EVRL (Model# EVRL) is indicated for use:
a. while using the red and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,
b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.
The Erchonia® Laser is applied externally and has proven through clinical trials to treat neck and shoulder pain with the red diode.
The components of the device consist of:
An ultra-slim hand-held battery-operated control device with a docking station providing two laser diodes a 640 nanometer and a 405 nanometer. Each laser diode emits its wavelength with a tolerance of ±10 nanometer. The lasers are powered by an internal battery that is recharged using a separate inductive charging base powered by an external class II medical power supply. This configuration offers portability as well as consistency of power.
The internal battery powers the two specially created and patented electronic diodes with an output of 7.5mW ± 1mW red and