The Erchonia® FX-405 (Model#: MLS-AC) 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 395nm to 415nm with a mean power output of 23.00mW. The Erchonia® FX-405 (Model#: MLS-AC) is a variable hertz device. The variable hertz feature of the Erchonia® FX-405 (Model#: MLS-AC) is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX-405 (Model#: MLS-AC) 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 can only be on or off; there is no user interface that allows the end user to alter the laserdiode output. 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 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, 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 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.

AI/ML Overview

The provided text describes an FDA 510(k) premarket notification for the Erchonia® FX-405 device, a low-level laser system indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.

Crucially, the document states: "No new clinical study results are being submitted as part of this [submission]. Clinical data previously reviewed in 510(k) submissions of the predicate device, the Erchonia® FX-635 Laser K190572, as well as the reference device, the Erchonia® EVRL Laser K191257 were provided to demonstrate safety of using the red and violet diodes simultaneously."

This means there is no new performance data or a new clinical study specifically conducted to establish acceptance criteria or prove device performance for the Erchonia® FX-405 in this submission. Instead, the submission relies on the substantial equivalence to previously cleared devices (predicate and reference devices) and data from their respective clinical trials.

Therefore, many of the requested details regarding acceptance criteria, study design, sample size, ground truth, and expert involvement for a new study are not applicable to this specific submission. The information provided relates to the comparison justifying substantial equivalence based on the technological characteristics and previously collected clinical data.

Based on the available information, here's a breakdown of what can and cannot be answered:

Acceptance Criteria and Reported Device Performance

There are no explicit "acceptance criteria" presented for a new clinical study of the FX-405 device in this document, as no new clinical study was performed. The "performance" being demonstrated is the substantial equivalence to the predicate and reference devices, implying that the FX-405 would achieve similar results as those demonstrated by the previous devices.

The table below summarizes the comparison of shared characteristics between the subject device (FX-405) and the predicate device (FX-635), which is used to argue substantial equivalence, rather than a direct performance outcome table for the FX-405 itself.

Characteristic	Acceptance Criteria (Implied by Predicate/Reference Performance)	Reported Device Performance (FX-405)
Indication for Use	Temporary relief of nociceptive musculoskeletal pain	Temporary relief of nociceptive musculoskeletal pain
Mechanism of Action	Stimulates mitochondria to increase ATP production	Stimulates mitochondria to increase ATP production
Safety Profile	Safe (as demonstrated by predicate and reference devices)	Safe (as demonstrated by predicate and reference devices)
Technological Equivalence	Comparable power, wavelength, energy source, energy delivery, treatment time (with the addition of a 405nm diode)	As per "Comparison of Technological Characteristics" table in the document

1. A table of acceptance criteria and the reported device performance

As stated above, no new clinical study was conducted for the FX-405. The "performance" is implicitly tied to the performance of the predicate and reference devices. The document does not provide a table of performance outcomes for the FX-405, but rather a comparison of its technical specifications to the predicate device leading to the conclusion of substantial equivalence.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable for a new study of the FX-405. The submission refers to clinical data from previous 510(k) clearances (K190572 for FX-635 and K191257 for EVRL). The sample sizes for those studies are not detailed in this document.
Data Provenance: Not specified in this document for the previously conducted studies (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: No new study with a "test set" and "ground truth" establishment was conducted for this specific submission of the FX-405. These details would pertain to the clinical trials supporting the predicate and reference devices, but are not provided here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: Similar to point 3, no details on adjudication methods for establishing ground truth are provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: The device is a low-level laser system for pain relief, not an AI-assisted diagnostic device involving human readers or image interpretation. Therefore, an MRMC study and AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: This is a physical therapy device, not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Relevant to previous studies: For the previous clinical studies that supported the predicate and reference devices, the "ground truth" for the device's efficacy would have been outcomes data related to nociceptive musculoskeletal pain relief (e.g., pain scores, functional improvement). The specifics are not detailed in this document.

8. The sample size for the training set

Not Applicable: This is not an AI/machine learning device with a "training set." The term "training set" is typically used in the context of data used to train AI models.

9. How the ground truth for the training set was established

Not Applicable: See point 8. No training set for an algorithm is discussed. The "ground truth" for previous clinical studies (on which this submission relies) would have been established through clinical assessments and patient-reported outcomes for pain relief, but the methodology details are not included in this document.

Summary

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November 12, 2021

Erchonia Corporation Travis Sammons Clinical Affairs 650 Atlantis Road Melbourne, Florida 32904

Re: K212595

Trade/Device Name: Erchonia® FX-405 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: NHN Dated: August 12, 2021 Received: August 16, 2021

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

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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 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

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Indications for Use

510(k) Number (if known) K212595

Device Name Erchonia® FX-405

Indications for Use (Describe)

The Erchonia® FX-405 laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.

Type of Use (Select one or both, as applicable)
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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 Road Melbourne, FL 32904 Contact: Steven Shanks Telephone: 321-473-1251 Fax: 321-473-1608 Email: sshanks@erchonia

Date Prepared

08/11/2021

Device Information

Trade Name: Erchonia® FX-405 Model#: MLS-AC 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: Phvsical Medicine Product Code: NHN

Predicate Device

Erchonia® FX-635 previously cleared under K190572.

Reference Device:

Erchonia EVRL Laser® (K191257)

The use of this reference device is justified as it points to a previous 510(k) market clearance that was granted to an Erchonia laser that emitted both 635nm red and 405nm violet lasers simultaneously to temporarily reduce minor chronic neck and shoulder pain of musculoskeletal origin. The 635nm red and 405mm violet wavelengths emitted by the Erchonia EVRL Laser® (K191257), are identical to the subject device, Erchonia® FX-405.

The Erchonia EVRL Laser® 510(k): K191257, was based on clinical data from a study that evaluated the safety and efficacy of the Erchonia Laser with both 635nm red and 405nm violet diodes activated simultaneously, in comparison to the efficiency of the Erchonia 635nm red diode only clinical trial whose results successfully supported 510(k) clearance K012580.

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Device Description

(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

Indication for Use

The Erchonia® FX-405 laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.

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Comparison of Technological Characteristics with the Predicate Device(s)

The Erchonia® FX-405 (MLS-AC) is substantially equivalent to the predicate device, the Erchonia® FX-635 previously submitted under K190572. Both the subject device and the predicate device have identical principles of operation, including wavelength, power, energy source, energy delivery, and treatment times. The only technological difference between the subject and predicate device is the addition of a single 405nm diode laser which does not render the device not substantially equivalent, does not affectiveness, or raise different questions of safety and effectiveness.

Additionally, the mechanism of the Erchonia® FX-405 is the exact same as the predicate device, Erchonia® FX-635 which stimulates the mitochondria to increase the production of ATP, as detailed in the substantially equivalent discussion Table 1 below.

Table 1.
Device	Erchonia® FX-405 (Model# MLS-AC)	Erchonia® FX-635 (Model# HPS)
510(k) #	K212595	K190572
	Subject Device	Predicate Device
	Image: Erchonia FX-405	Image: Erchonia FX-635
Number of diodes	(3) Red diodes(1) Violet diode	(3) Red diodes
Power per Diode(measured at aperture)	Red: 17.25mW ± 1.25mWViolet: 23mW ± 2mW	Red:17.25mW ± 1.25mW
Wavelength	Red: 630nm to 640nmViolet: 400nm to 410nm	Red: 630nm to 640nm
Energy Source	Multi diode collected then line dispersed(coherent)	Multi diode collected then linedispersed (coherent)
Treatment time	Variable depending on area beingtreated - refer to Owner's Manual	Variable depending on area beingtreated - refer to Owner's Manual
Total Joules PerMinute	2.25J	1.53J
J/cm² Per Minute	Red: .0035 J/cm²Violet: .0045 J/cm²	Red: .0035 J/cm²
Power Supply	1.5A/100VAC & 0.5A/240VAC, 50-60Hzelectrical outlet	1.5A/100VAC & 0.5A/240VAC,50/60Hz electrical outlet
Energy Delivery	Floor model device with probe head	Floor model device with probe head
Target Size	Line pattern, electronically scanned overarea of treatment	Line pattern, electronically scannedover area of treatment
Indication for Use	The Erchonia® FX-405 laser is indicatedfor the adjunctive use in providingtemporary relief of nociceptivemusculoskeletal pain.	The Erchonia® FX-635 laser isindicated for the adjunctive use in providingtemporary relief ofnociceptive musculoskeletal pain.
Principles of Operation	Mains power, converted to DC, poweringsemi-conductor diodes	Mains power, converted to DC,powering semi-conductor diodes
Mechanism of Action	Stimulates the mitochondria to increasethe production of ATP	Stimulates the mitochondria toincrease the production of ATP
Product Code	NHN	NHN

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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 complies with FDA's performance standards for light-emitting products (21CFR 1040.10 and 21 CFR 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 shelf-life because it is an electro-mechanical device that is not sterile and whose components will not degrade over time while simply sitting in storage prior to initial use.

Software

Software verification and validation testing was conducted 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. Cybersecurity 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 wireless communication interfaces (Wi-Fi, Bluetooth, RF, inductive, Cloud, etc.).

Performance Testing-Clinical

No new clinical study results are being submitted as part of this l data previously reviewed in 510(k) submissions of the predicate device, the Erchonia® FX-635 Laser K190572, as well as the reference device, the Erchonia® EVRL Laser K191257 were provided to demonstrate safety of using the red and violet diodes simultaneously.

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Treatment Protocol Comparison of the FX-405 (Subject device) and FX-635 (Predicate device)

The treatment protocols of the subject device, Erchonical to the protocols of the predicate device Erchonia® FX-635 (K#190572), which received FDA market clearance for adjunctive use in providing temporary relief of nociceptive musculoskeletal pain. Table 2 below provides a comparison of treatment protocols:

Table 2. Comparison of Treatment Protocols
Condition	Treatment Duration andFrequency	LaserWavelength	Power Output(mW)	Total JoulesPer Minute	Dutycycle	Frequency (Hz)
Chronic Neckand ShoulderPain	Single treatment to thesagittal suture, shoulder,cerebral, cervical and torsoregions for a combinedtotal of 13 minutes.	Erchonia FX-635(3) Red 635nmErchonia FX-405(3) Red 635nm(1) Violet 405nm	Erchonia FX-635635nm: 17.25mWErchonia FX-405635nm: 17.25mW405nm: 23mw	Erchonia FX-6351.53JErchonia FX-4052.25J	50%	The variable hertz is apulsed wave,containing a selectedseries of breaks,variances that arepreprogrammed.
Chronic LowBack Pain	8 20-minute treatments 2times/week for 4 weeksacross the lower backregion and hip flexors.	Erchonia FX-635(3) Red 635nmErchonia FX-405(3) Red 635nm(1) Violet 405nm	Erchonia FX-635635nm: 17.25mWErchonia FX-405635nm: 17.25mW405nm: 23mw	Erchonia FX-6351.53JErchonia FX-4052.25J	50%	The variable hertz is apulsed wave,containing a selectedseries of breaks,variances that arepreprogrammed.
Chronic HeelPain arisingfrom PlantarFasciitis	6 10-minute treatments 2times/week for 3 weeks tothe top of foot, myofascialjunction of the heel, andthe plantar aspect of theheel.	Erchonia FX-635(3) Red 635nmErchonia FX-405(3) Red 635nm(1) Violet 405nm	Erchonia FX-635635nm: 17.25mWErchonia FX-405635nm: 17.25mW405nm: 23mw	Erchonia FX-6351.53JErchonia FX-4052.25J	50%	The variable hertz is apulsed wave,containing a selectedseries of breaks,variances that arepreprogrammed.

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Substantially Equivalent Discussion

The Erchonia® FX-405 (MLS-AC) is substantially equivalent to the predicate device, the Erchonia® FX-635 previously submitted under K190572. Both the subject device have identical principles of operation, including wavelength, power, energy source, energy delivery, and treatment time. The only technological difference between the subject and predicate device is the addition of a single 405nm diode laser which does not render the device not substantially equivalent, does not affect the safety or effectiveness, or raise different questions of safety and effectiveness.

Erchonia Corporation has documented the safety of simultaneously administering the combination of 635nm red and 405nm violet diodes, in clinical data previously reviewed under K191257. In particular, the provided reference device (Erchonia® EVRL) provides clinical data that demonstrated the use of the Erchonia 635nm red and 405nm violet laser diodes when administered simultaneously to be safe when "providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin", under FDA market clearance K191257.

Conclusion

The subject device and predicate device have identical power, wavelength, energy source, and treatment time. The only technological difference between the subject and the predicate devices (i.e., slightly greater energy to be delivered [2.25 vs. 1.53 Joules per minute] by including one extra violet diode) does not render the subject device not substantially equivalent to the predicate device, affect the safety or effectiveness, or raise questions regarding the safety and effectiveness.

The physiological effect of the Erchonia 635mm red laser is as safe and as effective for providing temporary relief of nociceptive musculoskeletal pain as the predicate device, cleared under K190572. Erchonia clinical data previously reviewed in K190572 demonstrated when administering the Erchonia 635nm diode simultaneously with the Erchonia 405nm diode, the synergistic effects of both laser wavelengths maintains the same safety profile as when the 635nm diode is use alone. Therefore, the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.