(87 days)
Not Found
No
The description details preprogrammed settings and a fixed output, with no mention of adaptive learning, data analysis for decision making, or any terms associated with AI/ML.
Yes
The device is indicated for adjunctive use in providing temporary relief of nociceptive musculoskeletal pain, which is a therapeutic purpose.
No
The text explicitly states that the device is "indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain," which describes a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines numerous hardware components including laser diodes, a mobile base, power cord, transformer, wheels, touch screen, PCB, adjustable arm, and laser head assembly. While it contains software, it is an integral part of a physical medical device.
Based on the provided information, the Erchonia® FX-635 laser is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "adjunctive use in providing temporary relief of nociceptive musculoskeletal pain." This describes a therapeutic application, not a diagnostic one.
- Device Description: The description details a low-level laser system that applies light externally to the patient's skin. This is a physical treatment modality.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on biological samples outside of the body to provide diagnostic information. The Erchonia® FX-635 laser is a therapeutic device that applies energy to the body for pain relief.
N/A
Intended Use / Indications for Use
The Erchonia® FX-635 laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.
Product codes (comma separated list FDA assigned to the subject device)
NHN
Device Description
The Erchonia® FX-635 (Model#: HPS) is low level laser system that uses three semi-conductor diodes (visible red-light) 630nm to 650mm. The Erchonia® FX-635 (Model#: HPS) is a variable hertz device. The variable hertz feature of the Erchonia® FX-635 (Model#: HPS) is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX 635 (Model#: HPS) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 Laser.
The Erchonia® FX 635, model: HPS laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain. The Erchonia® Laser is applied externally and has proven through clinical trials to treat the neck, shoulder, low back and plantar fasciitis.
The components of the device include a mobile base which plugs into the wall, using a hospital grade power cord, equipped with a medical grade transformer. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power. Four (4) antistatic wheels that enable ease for maneuverability. A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The laser diodes can only be on or off; there is no user interface that allows the end user to alter the laser diode output. The low back protocol and heel pain protocol is factory set and cannot be altered by the end user. The device has an adjustable main arm that is attached to the mobile base with the laser head assembly located at the end. The adjustable main arm is capable to collapse into the mobile base for storage and transporting or extends to position the laser heads above the area of involvement. The laser head assembly that is attached to the adjustable main arm that is manually raised and lowered, utilizes internal mechanics that collects the light emitted from each of the three (3) laser diodes that rotate in a spiraling circle pattern that is totally random and independent of the other diodes. The laser head assembly is positioned 3-4 inches from the patient's skin to deliver treatment for pain. This assembly can be rotated 120 degrees for proper positioning to patient for accurate treatment. The laser head assembly includes arms and pivots that allow the three (3) laser output heads to be rotated, tilted, and raised / lowered independently. The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons; work in conjunction with the component platform to ensure the device operates as intended.
The associated accessories include:
- Hospital grade power cord
- Patient protective eyewear
- Power safety lockout keys
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neck, shoulder, low back and plantar fasciitis
Indicated Patient Age Range
Adults
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing of the Erchonia FX-635™ Laser device included three pivotal studies evaluating reduction of chronic neck and shoulder pain, chronic low back pain and heel pain arising from plantar fasciitis. A total of 213 subjects were evaluated across all three studies. Each of these pivotal studies was used to support clearance of the respectively evaluated indications. Substantial equivalence is based in part on these three pivotal studies.
Pivotal Study 1: Study of the Effectiveness of the TUCO Erchonia PL2000 in Providing Temporary Relief of Minor Neck and/or Shoulder Pain of Chronic Origin
- Study type: prospective, multi-center, randomized, double-blinded and placebo controlled multi-arm study
- Sample size: 100 subjects enrolled, 86 available for primary endpoint analysis (43 Investigational Device Arm, 43 Control Arm)
- Key results:
- Primary effectiveness endpoint: 65.1% of actively treated subjects attained individual success (30% or greater improvement in 0-100 VAS pain rating) compared with 11.6% of control (placebo) subjects, resulting in a 53.5% difference between treatment groups (p
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 1, 2019
Erchonia Corporation % Steven Shanks President 650 Atlantis Road Melbourne, FL 32904
Re: K190572
Trade/Device Name: Erchonia® FX-635 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: NHN Dated: March 5, 2019 Received: March 6, 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.
1
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
Vivek Pinto, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190572
Device Name Erchonia ® FX-635
Indications for Use (Describe)
The Erchonia® FX-635 laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.
| Type of Use (Select one or both , as applicable) |
|---|
| --------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Road Melbourne, FL 32904 Contact: Mr. Steven Shanks Telephone: 321-473-1251 Fax: 321-473-1608 Email: sshanks@erchonia.com
Date Prepared
2/28/2019
Device Information
Trade Name: Erchonia® FX-635 Model#: HPS 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
Predicate Device
The Erchonia® FX-635 (Model# HPS) is substantially equivalent to the following primary predicate device: Erchonia® FX-635 (Model# HPS) K180197 Additionally the Erchonia® FX-635 (Model# HPS) is substantially equivalent to the following secondary predicate device(s):
4
Erchonia® Allay (Model# HPS) K132940 as well as the TUCO Erchonia® PL2000 (Model# PL2) K012580
The Erchonia® FX-635 is the same model as the Erchonia® FX-635 previously submitted under K180197.
Device Description
The Erchonia® FX-635 (Model#: HPS) is low level laser system that uses three semi-conductor diodes (visible red-light) 630nm to 650mm. The Erchonia® FX-635 (Model#: HPS) is a variable hertz device. The variable hertz feature of the Erchonia® FX-635 (Model#: HPS) is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX 635 (Model#: HPS) has been classified by the FDA/EC as a Class II/Ila device and a Class II/2 Laser.
The Erchonia® FX 635, model: HPS laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain. The Erchonia® Laser is applied externally and has proven through clinical trials to treat the neck, shoulder, low back and plantar fasciitis.
The components of the device include a mobile base which plugs into the wall, using a hospital grade power cord, equipped with a medical grade transformer. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power. Four (4) antistatic wheels that enable ease for maneuverability. A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The laser diodes can only be on or off; there is no user interface that allows the end user to alter the laser diode output. The low back protocol and heel pain protocol is factory set and cannot be altered by the end user. The device has an adjustable main arm that is attached to the mobile base with the laser head assembly located at the end. The adjustable main arm is capable to collapse into the mobile base for storage and transporting or extends to position the laser heads above the area of involvement. The laser head assembly that is attached to the adjustable main arm that is manually raised and lowered, utilizes internal mechanics that collects the light emitted from each of the three (3) laser diodes that rotate in a spiraling circle pattern that is totally random and independent of the other diodes. The laser head assembly is positioned 3-4 inches from the patient's skin to deliver treatment for pain. This assembly can be rotated 120 degrees for proper positioning to patient for accurate treatment. The laser head assembly includes arms and pivots that allow the three (3) laser output heads to be rotated, tilted, and raised / lowered independently. The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons; work in conjunction with the component platform to ensure the device operates as intended.
The associated accessories include:
- Hospital grade power cord ●
- Patient protective eyewear ●
- Power safety lockout keys ●
5
Intended Use
The Erchonia® FX-635 laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.
Comparison of Technological Characteristics with the Predicate Device
The Erchonia® FX-635 is equivalent to the primary predicate device, Erchonia® FX 635 manufactured by Erchonia® as well as the secondary predicate device(s) the Erchonia® Allay as well as the TUCO Erchonia® PL2000. The principles of operation of the Erchonia® FX-635 are identical in every aspect to the previously cleared Erchonia® FX 635.
| Device | Erchonia® FX-
635 (Model#
HPS) | Erchonia® FX-
635 (Model#
HPS) | Erchonia®
Allay (Model#
HPS) | TUCO
Erchonia®
PL2000 |
|------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 510(k) # | N/A | K180197 | K132940 | K012580 |
| Power
(measured at
aperture) | 17.25mW ±
1.25mW | 17.25mW ±
1.25mW | 17.25mW ±
1.25mW |