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.

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.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria. Instead, it describes a 510(k) premarket notification for the Erchonia FX-405, where substantial equivalence to predicate devices is established.

The document highlights the device's characteristics and compares them to existing cleared devices (Erchonia FX-405, K212595 as primary predicate, and Erchonia XLR8, K211186 as secondary predicate) to demonstrate that the new device is as safe and effective.

Here's an analysis of the information that is not present in the provided text, based on your request:

Table of acceptance criteria and reported device performance: This is not present. The document focuses on demonstrating substantial equivalence to predicate devices, not on setting and meeting specific performance metrics against pre-defined acceptance criteria.
Sample size used for the test set and data provenance: No clinical test set data is presented in this 510(k) summary, as stated in the "Performance Testing-Clinical" section: "No clinical data was used to establish Substantial Equivalence."
Number of experts used to establish ground truth and qualifications: Not applicable, as no clinical test set with ground truth was used for this submission.
Adjudication method for the test set: Not applicable, as no clinical test set with ground truth was used.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned and not performed, as no clinical data was used for substantial equivalence.
Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable. The Erchonia FX-405 is a physical laser device, not an AI algorithm.
Type of ground truth used: Not applicable, as no clinical test set requiring ground truth was used.
Sample size for the training set: Not applicable, as this is a physical device and not an AI/machine learning algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable, as this is a physical device and not an AI/machine learning algorithm.

Summary of available information related to performance and equivalence:

The document states that "No clinical data was used to establish Substantial Equivalence." Instead, the submission relies on a comparison of technological characteristics with predicate devices and compliance with voluntary and performance standards.

The device is substantially equivalent to the primary predicate device (Erchonia FX-405, K212595) because it is described as the "exact same model." For the secondary predicate (Erchonia XLR8, K211186), equivalence is established by comparing technical specifications:

Wavelength, Energy Source, Mechanism of Action: Identical to the secondary predicate (Erchonia XLR8).
Number of Diodes, Power, Total Joules Per Minute: Differences are deemed "negligible" and not affecting safety or effectiveness when applied over the treatment area.
Recommended Treatment Duration: Same for the Indications for Use (IFU) regarding postoperative pain.
Energy Delivery & Target Size: Differences in floor model vs. handheld, and electronically scanned vs. manually scanned, are stated not to change the physiological mechanism or affect safety/effectiveness.
Indications for Use: The subject device's indication for adjunctive treatment of postoperative pain (using red diodes) is identical to one of the XLR8's indications. The added indication for nociceptive musculoskeletal pain (red and violet diodes) is covered by the primary predicate.

Performance Data (General Compliance, not specific acceptance criteria):

Compliance with 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: Complies with FDA's performance standards for light-emitting products (21CFR 1040.11 by Laser Notice #50).
Software: Software verification and validation testing conducted, classified as "minor" level of concern. No patient data storage, no cybersecurity risk of safety or effectiveness, no wireless interfaces.
Biocompatibility: Not applicable, as the device does not contact patient skin or tissue.
Sterilization and Shelf-Life: Not provided sterile; device is electro-mechanical, components will not degrade during storage.

Therefore, the "study" referred to in the prompt is essentially the technical comparison and compliance with standards presented in the 510(k) summary, rather than a clinical trial or performance study against specific acceptance criteria.

Summary

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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

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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 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

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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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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.

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Device Description

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.

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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 andSecondary Predicate Device
510(k) #	K231409	K212595	K211186
	Subject Device	Primary Predicate Device	Secondary Predicate Device
Wavelength	Red: 630nm to 640nmViolet: 400nm to 410nm	Red: 630nm to 640nmViolet: 400nm to 410nm	Red: 640 ± 10	Both devices emit identical red wavelength
Number of Diodes	3 Red1 Violet	3 Red1 Violet	2 Red	The subject device enables the user toselect the application of one to threediodes, therefore the number of diodes isidentical or equivalent (does not affectsafety or effectiveness) to the applicationof two diodes with the secondary predicatedevice.
Power (measured ataperture)	Red: 17.25mW ± 1.25mWViolet: 23mW ± 2mW	Red: 17.25mW ± 1.25mWViolet: 23mW ± 2mW	Red: 7.5mW ± 2mW	Difference in power is negligible (does notaffect safety or effectiveness) whenapplied 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 isnegligible (does not affect safety oreffectiveness) when applied over thetreatment area.
Recommended treatmentduration	0 - 20 minutes	0 - 20 minutes	0 - 12 minutes	Both devices have the same recommendedtreatment time for the IFU, as anadjunctive treatment of postoperative pain
J/cm2 per minute	Red: .0035 J/cm2Violet: .0045 J/cm2	Red: .0035 J/cm2Violet: .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; 12Vdc1.5A) that connect to the InductiveCharging Base -(1.5A 12V), to charge theBattery (Lithium-ionPolymer 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 notaffect treatment safety or effectiveness
Target Size	Line pattern, electronically scannedover area of treatment	Line pattern, electronically scanned overarea of treatment	Line pattern, manually scanned overarea of treatment	No difference in line pattern beam. Thedifference in electronically scanned ormanually scanned does not change thephysiological mechanism of the ErchoniaCorporation 635nm diode laser forproviding pain reduction and does not affectsafety or effectiveness.
Indication for Use	The Erchonia® FX-405 laser isgenerally indicated:a.while using the red and violetdiodes, for the adjunctive usein providing temporary reliefof nociceptivemusculoskeletal pain.b.and while using the reddiodes, as an adjunctivetreatment of postoperativepain.	The Erchonia® FX-405 laser is indicatedfor the adjunctive use in providingtemporary relief of nociceptivemusculoskeletal pain.	The Erchonia® XLR8 is generallyindicated:a. as adjunctive use in providingtemporary relief of minor chronic neckand shoulder pain of musculoskeletalorigin.b. as an adjunct to liposuctionprocedures of the thighs, hips andstomach for reduction of pain associatedwith the recovery process.c. for the temporary reduction in post-surgery pain at 24 hours after surgeryfollowing bilateral breast augmentationsurgery.d. as an adjunctive treatment ofpostoperative pain	No difference in IFU. Both devices areindicated while using red diodes, as anadjunctive 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 toincrease the production of ATP	Stimulates the mitochondria to increasethe production of ATP	Stimulates the mitochondria to increasethe production of ATP	Same
Product Code	NHN	NHN	NHN	Same

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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.

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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 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.

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.