(88 days)
Not Found
No
The device description focuses on hardware components, preprogrammed settings, and basic software for user interface and control. There is no mention of learning, adaptation, or data-driven decision-making, which are characteristic of AI/ML.
Yes
The device is indicated for providing temporary relief of nociceptive musculoskeletal pain and as an adjunctive treatment of postoperative pain, which are therapeutic uses.
No
The device is indicated for providing temporary relief of nociceptive musculoskeletal pain and as an adjunctive treatment of postoperative pain, which are therapeutic uses, not diagnostic. It does not mention any capability to diagnose or identify medical conditions.
No
The device description clearly outlines numerous hardware components including laser diodes, a mobile base, a touch screen, a main arm, and a laser head assembly. While it mentions software loaded into PCB drivers, the device is fundamentally a hardware system that utilizes software for control and interface.
Based on the provided information, the Erchonia® FX-405 laser is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the temporary relief of musculoskeletal pain and as an adjunctive treatment of postoperative pain. These are therapeutic applications, not diagnostic ones.
- Device Description: The description details a laser system that emits light for therapeutic purposes. There is no mention of analyzing biological samples (blood, urine, tissue, etc.), which is a core function of IVD devices.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening.
In summary, the Erchonia® FX-405 is a therapeutic device that uses laser energy to treat pain, not a diagnostic device that analyzes samples to provide medical information.
N/A
Intended Use / Indications for Use
The Erchonia® FX-405 laser is generally indicated:
a. while using the red and violet diodes, for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.
b. and while using the red diodes, as an adjunctive treatment of postoperative pain.
Product codes
NHN
Device Description
Erchonia® FX-405 is low level laser system that uses three semi-conductor diodes (visible light) 630nm to 650nm with a mean power output of 17.25mW per diode and one semi-conductor diode 400nm to 410nm with a mean power output of 23.00mW. The Erchonia®FX-405 is a variable hertz device. The variable hertz feature of the Erchonia® FX-405 is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX-405 has been classified by the FDA/EC as a Class II device and a Class 2 Laser. 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. 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 device has an adjustable main arm that is attached to the mobile baser 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 four (4) laser diodes and processes each through a proprietary patented lens which redirects the beam with a line refracted light is then bent into a spiraling circle pattern that is totally random and independent of the other diodes. 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 four (4) laser output heads to be rotated, titled, 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 exterior materials consist of 6061 T6 AL, Kydex 430 and Copolymer Acetal with powder coating and carbon fiber finish.
The associated accessories include:
- (1) Hospital grade power cord
- (1) Patient protective eyewear (sufficiently and effectively block the laser light spectrum at OD 2+ @ 635nm, . OD 0.75 @ 405nm VLT60)
- (2) Power safety lockout keys
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
No clinical data was used to establish Substantial Equivalence
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
August 11, 2023
Erchonia Corporation Travis Sammons Clinical Affairs Manager 650 Atlantis Road Melbourne, Florida 32904
Re: K231409
Trade/Device Name: Erchonia FX-405 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: NHN Dated: May 8, 2023 Received: May 15, 2023
Dear Travis Sammons:
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
1
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 (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 mediation-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,
Amber T. Ballard -S
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine 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) K231409
Device Name Erchonia® FX-405
Indications for Use (Describe)
The Erchonia® FX-405 laser is generally indicated:
a. while using the red and violet diodes, for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.
b. and while using the red diodes, as an adjunctive treatment of postoperative pain.
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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3
510(k) Summary K231409
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: Travis Sammons Telephone: 321-473-1251 Fax: 321-473-1608 Email: tsammons@erchonia.com
Date Prepared
8/10/2023
Device Information
Trade Name: Erchonia® FX-405 Common Name: Infrared Lamp Classification Name: Powered Light Based Laser Non-Thermal With Non-Heating Effect For Adjunctive Use In Pain Therapy (21 CFR 890.5500) Classification: Class II Panel: Physical Medicine Product Code: NHN
Predicate Devices
Primary Predicate Device: Erchonia® FX-405 cleared under K212595. Secondary Predicate Device: Erchonia® XLR8 cleared under K211186.
4
Device Description
Erchonia® FX-405 is low level laser system that uses three semi-conductor diodes (visible light) 630nm to 650nm with a mean power output of 17.25mW per diode and one semi-conductor diode 400nm to 410nm with a mean power output of 23.00mW. The Erchonia®FX-405 is a variable hertz device. The variable hertz feature of the Erchonia® FX-405 is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX-405 has been classified by the FDA/EC as a Class II device and a Class 2 Laser. 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. 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 device has an adjustable main arm that is attached to the mobile baser 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 four (4) laser diodes and processes each through a proprietary patented lens which redirects the beam with a line refracted light is then bent into a spiraling circle pattern that is totally random and independent of the other diodes. 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 four (4) laser output heads to be rotated, titled, 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 exterior materials consist of 6061 T6 AL, Kydex 430 and Copolymer Acetal with powder coating and carbon fiber finish.
The associated accessories include:
- (1) Hospital grade power cord ●
- (1) Patient protective eyewear (sufficiently and effectively block the laser light spectrum at OD 2+ @ 635nm, . OD 0.75 @ 405nm VLT60)
- (2) Power safety lockout keys
Indications for Use
The Erchonia® FX-405 laser is generally indicated:
- a. while using the red and violet diodes, for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.
- b. and while using the red diodes, as an adjunctive treatment of postoperative pain.
5
Comparison of Technological Characteristics with the Predicate Devices
The subject device (Erchonia® FX-405) is the exact same model as the primary predicate device (Erchonia® FX- 405) previously cleared under K212595. The subject device (Erchonia® FX-405) and secondary predicate device (Erchonia® XLR8) have identical wavelength, energy source, and mechanism of action. There are no differences between the subject that render that render the subject device not substantially equivalent nor affect safety or effectiveness.
| Device | Erchonia® FX-405 | Erchonia® FX-405 | Erchonia® XLR8 | Difference Between Subject Device and
Secondary Predicate Device |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K231409 | K212595 | K211186 | |
| | Subject Device | Primary Predicate Device | Secondary Predicate Device | |
| Wavelength | Red: 630nm to 640nm
Violet: 400nm to 410nm | Red: 630nm to 640nm
Violet: 400nm to 410nm | Red: 640 ± 10 | Both devices emit identical red wavelength |
| Number of Diodes | 3 Red
1 Violet | 3 Red
1 Violet | 2 Red | The subject device enables the user to
select the application of one to three
diodes, therefore the number of diodes is
identical or equivalent (does not affect
safety or effectiveness) to the application
of two diodes with the secondary predicate
device. |
| Power (measured at
aperture) | Red: 17.25mW ± 1.25mW
Violet: 23mW ± 2mW | Red: 17.25mW ± 1.25mW
Violet: 23mW ± 2mW | Red: 7.5mW ± 2mW | Difference in power is negligible (does not
affect safety or effectiveness) when
applied over the treatment area. |
| Energy Source | Diode collected then line dispersed
(coherent) | Diode collected then line dispersed
(coherent) | Diode collected then line dispersed
(coherent) | Same |
| Total Joules Per Minute
(50% duty cycle) | 2.25 | 2.25 | .45 | Difference in total joules per minute is
negligible (does not affect safety or
effectiveness) when applied over the
treatment area. |
| Recommended treatment
duration | 0 - 20 minutes | 0 - 20 minutes | 0 - 12 minutes | Both devices have the same recommended
treatment time for the IFU, as an
adjunctive treatment of postoperative pain |
| J/cm2 per minute | Red: .0035 J/cm2
Violet: .0045 J/cm2 | Red: .0035 J/cm2
Violet: .0045 J/cm2 | Not Publicly Available | Information not publicly available |
| Power Supply | 1.5A/100VAC & 0.5A/240VAC,
50-60Hz electrical outlet | 1.5A/100VAC & 0.5A/240VAC, 50-
60Hz electrical outlet | External Power Supply -(100- 240Vac, 50-
60Hz, 0.5A; 12Vdc
1.5A) that connect to the Inductive
Charging Base -(1.5A 12V), to charge the
Battery (Lithium-ion
Polymer 3.7V, 1800mAh, 6.7W) | Safety and EMC testing conducted. |
| Energy Delivery | Floor model device with probe head | Floor model device with probe head | Handheld treatment probe | Difference in energy delivery does not
affect treatment safety or effectiveness |
| Target Size | Line pattern, electronically scanned
over area of treatment | Line pattern, electronically scanned over
area of treatment | Line pattern, manually scanned over
area of treatment | No difference in line pattern beam. The
difference in electronically scanned or
manually scanned does not change the
physiological mechanism of the Erchonia
Corporation 635nm diode laser for
providing pain reduction and does not affect
safety or effectiveness. |
| Indication for Use | The Erchonia® FX-405 laser is
generally indicated:
a.
while using the red and violet
diodes, for the adjunctive use
in providing temporary relief
of nociceptive
musculoskeletal pain.
b.
and while using the red
diodes, as an adjunctive
treatment of postoperative
pain. | The Erchonia® FX-405 laser is indicated
for the adjunctive use in providing
temporary relief of nociceptive
musculoskeletal pain. | The Erchonia® XLR8 is generally
indicated:
a. as adjunctive use in providing
temporary relief of minor chronic neck
and shoulder pain of musculoskeletal
origin.
b. as an adjunct to liposuction
procedures of the thighs, hips and
stomach for reduction of pain associated
with the recovery process.
c. for the temporary reduction in post-
surgery pain at 24 hours after surgery
following bilateral breast augmentation
surgery.
d. as an adjunctive treatment of
postoperative pain | No difference in IFU. Both devices are
indicated while using red diodes, as an
adjunctive treatment of postoperative pain. |
| Principles of Operation | Mains power, converted to DC,
powering semi-conductor diodes | Mains power, converted to DC,
powering semi-conductor diodes | DC, powering semi-conductor diodes | Safety and EMC testing conducted. |
| Mechanism of Action | Stimulates the mitochondria to
increase the production of ATP | Stimulates the mitochondria to increase
the production of ATP | Stimulates the mitochondria to increase
the production of ATP | Same |
| Product Code | NHN | NHN | NHN | Same |
6
Substantially Equivalent Discussion
The subject device (Erchonia® FX-405) is the exact same model as the primary predicate device (Erchonia® FX-405) previously cleared under K212595, "for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain". The subject device (Echonia® FX-405) and secondary predicate device both emit the Erporation 635mm diode laser with identical wavelength, energy source, and mechanism of action.
The treatment for postoperative pain with the Erchonia® XLR8 is established upon the utilization of the Erchonia Corporation 635nm diode laser with identical wavelength and laser characteristics. The difference in output of Jour per minute is negligible and does not affect the safety or effectiveness of the treatment.
The difference in application of treatment (manned) device does not change the physiological mechanism of the Erchonia Corporation 635nm diode laser for providing pain reduction.
7
Performance Data
Compliance with Voluntary Standards
The Erchonia® FX-405 complies with the following voluntary standards: IEC 60601-1-2:2014 Edition 4.0 IEC 60601-1:2005 Edition 3.1 IEC 60825-1:2014 Edition 3.0
Performance Standards
The Erchonia® FX-405 compliss with FDA's performance standards for light-emitting products (21CFR 1040.11 by Laser Notice #50).
Biocompatibility
Not applicable. The device does not come in contact with the patient's skin or any other bodily tissue.
Sterilization and Shelf-Life
The device is not provided sterile.
The device is not affected by shelfie because it is an electro-mechanical device that is not sterile and whose components will not degrade ver time while simply sitting in storage prior to initial use.
Software
Software verification and validation testing was conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software in Medical Devices." The software for this device was considered as a "minor" level of concern.
The Erchonia® FX-405 does not store any patient data. Orbersecurity is not considered a security or safety risk to users, nor does it pose a risk of safety or effectiveness. The Erchonia® FX-405 Laser does not contain wirefaces (Wi-Fi, Bluetooth, RF, inductive, Cloud, etc.).
Performance Testing-Clinical
No clinical data was used to establish Substantial Equivalence
Conclusion
The subject device is as safe, as effective, and performs as well as the legally marketed devices Erchonia® XLR8. The subject device is substantially equivalent to the Erchonia® FX-405 and Erchonia® XLR8.