a. while using the green 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.

Device Description

The Erchonia® GVL (Model# GVL) is a low-level laser system that uses two semi-conductor diodes (visible green and violet light), green: 520 nm and violet: 405 nm ± 10. The Erchonia® GVL (Model# GVL) is a variable hertz device. The variable hertz feature of the Erchonia® GVL (Model# GVL) is a pulsed wave, defined as containing a selected series of breaks, variances. The Erchonia® GVL (Model# GVL) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 laser.

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 520 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 green and <5mW violet non-convergent beam and is classified as a Class 2 laser in accordance IEC 60825-1 (Complies with 21CFR 1040.10 and 21 CFR 1040.11 by Laser Notice #50). The separate inductive charging base runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power.

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 Erchonia® GVL (Model# GVL) as designed contains user protocols. The user protocols are defined and saved by the user in one of ten memory locations and can be changed at any time. User instructions are provided in the Erchonia® GVL Operation & Maintenance Manual for proper touchscreen interface operation for the user to set laser diode variable hertz and length of treatment time. There is no interface that allows the end user the laser power output (milliwatts) or the laser wavelength (nanometers).

The Acne protocol is factory set and cannot be altered by the end user.

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:

Charging Base .
Power Supply
. Patient protective eyewear

AI/ML Overview

This document describes the Erchonia® GVL device, which is an infrared lamp cleared for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin (using green and violet diodes simultaneously) and to treat moderate inflammatory Acne Vulgaris (using the violet diode). The device's substantial equivalency is based on a comparison to the Erchonia® EVRL (predicate device).

Here's the information about the acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

For temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin:

Acceptance Criteria (Overall Study Success Criteria)	Reported Device Performance (Erchonia® GVL)
75% ± 5% of individual subject successes	81.4% of subjects attained individual success

Individual subject success was pre-established as a 30% or greater decrease in Visual Analog Scale (VAS) rating at endpoint relative to baseline.

2. Sample Size Used for the Test Set and Data Provenance

The study was a single-group non-inferiority design.

Test Set Sample Size: 43 subjects completed the study for the Erchonia® GVL device.
Data Provenance: The document does not explicitly state the country of origin. The study was prospective, as it involved administering the Erchonia® GVL to new subjects. The comparative data for the predicate device (Erchonia® EVRL) was attained from a 2019 trial, which would also be considered prospective at the time it was conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the test set was based on self-reported Visual Analog Scale (VAS) pain ratings from subjects, not expert medical assessment for individual cases. Therefore, this section is not applicable in the traditional sense of medical image or diagnostic device evaluation.

4. Adjudication Method for the Test Set

The adjudication method for the test set (regarding pain relief) was based on individual subject self-reporting of VAS pain ratings, with success defined as a 30% or greater decrease from baseline. There was no mention of an expert adjudication panel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study was a non-inferiority clinical study comparing the device to a previously established predicate device's clinical trial results. The outcome measure (VAS pain rating) is a subjective patient-reported outcome, not an interpretation by multiple readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is a physical medical device (laser system), not an algorithm or AI system for diagnosis or interpretation. Therefore, a standalone (algorithm only) performance study is not applicable. The performance evaluated was the direct effect of the device on patients.

7. The Type of Ground Truth Used

The ground truth used for the pain indication was patient-reported outcomes, specifically the change in Visual Analog Scale (VAS) neck and shoulder pain ratings.

8. The Sample Size for the Training Set

The document describes a clinical study for the Erchonia® GVL device. This study is a non-inferiority clinical trial to demonstrate effectiveness, not a study for training an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The clinical data from the Erchonia® EVRL 2019 trial (n=44) and the Erchonia® PL2000/EVRL (K012580, K152196) (n=43) serve as comparative effectiveness data from prior studies, not training data for the subject device's approval.

9. How the Ground Truth for the Training Set Was Established

As noted above, there is no "training set" in the machine learning sense for this device. The comparative data (from previous trials for the Erchonia® EVRL and PL2000) also used patient-reported outcomes (VAS pain ratings) as their ground truth for establishing effectiveness.

Summary

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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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".

September 1, 2022

Erchonia Corporation Travis Sammons Contact Address

Re: K221987

Trade/Device Name: Erchonia® GVL Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: NHN, GEX Dated: June 30, 2022 Received: July 6, 2022

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 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

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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,

Jianting Wang Acting Assistant Director 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) K221987

Device Name Erchonia® GVL

Indications for Use (Describe)

The Erchonia® GVL laser is generally indicated:

a. while using the green 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)
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☑ Residential Use (Part 21 CFR 201.326(a) Subject Clause)
□ Over-The-Counter Use (21 CFR 201.326(c) Subject Clause)

X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K221987

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: Travis Sammons Telephone: 321-473-1251 Fax: 321-473-1608 Email: tsammons@erchonia.com

Date Prepared

09/01/2022

Device Information

Trade Name: Erchonia® GVL Model#: GVL 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, GEX

Predicate Device

Erchonia® EVRL (Model# EVRL) cleared under K191257.

Reference Device

Erchonia® EVRL (Model# EVRL) cleared under K152196.

The use of this reference device provides the regulatory background of the safety and effectiveness of Erchonia low-level lasers in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

The Erchonia® PL2000, a red (635 nm) diode laser was evaluated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin in a doubleblinded, sham-controlled, randomized clinical trial, the results of which successfully supported an

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FDA clearance under K012580 for the following indication:

"The TUCO Erchonia PL2000 is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin."

The TUCO Erchonia PL2000 was subsequently renamed the Erchonia® EVRL (reference device), and its indications updated under K152196 to include both the treatment of neck and shoulder pain as well as acne vulgaris, as follows:

"The Erchonia EVRL Laser is generally indicated: a. while using the red diode, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin, and b. while using the blue diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris"

Device Description

The Erchonia® GVL (Model# GVL) is identical to the predicate device, the Erchonia® EVRL cleared under K191257, including device enclosure, functionally and software. The only difference between the Erchonia® GVL and the Erchonia® EVRL is the color of laser emission (green and violet as a replacement for red and violet).

The components of the device consist of:

The Acne protocol is factory set and cannot be altered by the end user.

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The associated accessories include:

Charging Base .
Power Supply
. Patient protective eyewear

Intended Use

The Erchonia® GVL laser is generally indicated:

a. while using the green 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.

Device	Erchonia® GVL (Model#GVL)	Erchonia® EVRL (Model#EVRL)	Erchonia® EVRL (Model#EVRL)
510(k) #	K221987	K191257	K152196
	Subject Device	Predicate Device	Reference Device
	Image: Erchonia GVL	Image: Erchonia EVRL	Image: Erchonia EVRL
Power(measured ataperture)	Green: 7.5mW± 1mWViolet: <5mW	Red: 7.5mW± 1mWViolet: <5mW	Red: 7.5mW± 1mWViolet: <5mW
Wavelength	Violet: 405nm ± 10Green: 520nm ± 10	Violet: 405nm ± 10Red: 640nm ± 10	Violet: 405nm ± 10Red: 640nm ± 10
Energy Source	diode laser energy collected thendispersed via line generatingoptics	diode laser energy collected thendispersed via line generatingoptics	diode laser energy collected thendispersed via line generatingoptics
Treatment Time	Acne: approx. 24 min.Neck and Shoulder Pain: 0-13 min.	Acne: approx. 24 min.Neck and Shoulder Pain: 0-13min.	Acne: approx. 24 min.Neck and Shoulder Pain: 0-13min.
Total Joules PerMinute	Green: .45Violet: .30	Red: .45Violet: .30	Red: .45Violet: .30
Power Supply	Lithium ion Polymer 3.7V,3000mAh, 11.2W, rechargeablebatteries	Lithium ion Polymer 3.7V,3000mAh, 11.2W, rechargeablebatteries	Lithium ion Polymer 3.7V,3000mAh, 11.2W, rechargeablebatteries
Energy Delivery	Device hand-held, probe on top	Device hand-held, probe on top	Device hand-held, probe on top

Device Comparison Table

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Target Size	Line pattern, manually scannedover area of treatment	Line pattern, manually scannedover area of treatment	Line pattern, manually scannedover area of treatment
Indications forUse	The Erchonia® GVL laser isgenerally indicated:a. while using the green and violetdiode simultaneously, foradjunctive use in providingtemporary relief of minor chronicneck and shoulder pain ofmusculoskeletal originb. and while using the violetdiode, to treat dermatologicalconditions, and specificallyindicated to treat moderateinflammatory Acne Vulgaris.	The Erchonia® EVRL laser isgenerally indicated:a. while using the red and violetdiode simultaneously, foradjunctive use in providingtemporary relief of minorchronic neck and shoulder painof musculoskeletal originb. and while using the violetdiode, to treat dermatologicalconditions, and specificallyindicated to treat moderateinflammatory Acne Vulgaris.	The Erchonia® EVRL laser isgenerally indicated:a. while using the red diode, foradjunctive use in providingtemporary relief of minor chronicneck and shoulder pain ofmusculoskeletal originb. and while using the violetdiode, to treat dermatologicalconditions, and specificallyindicated to treat moderateinflammatory Acne Vulgaris.
Mechanism of	Stimulates the mitochondria toincrease the production of ATP	Stimulates the mitochondria toincrease the production of ATP	Stimulates the mitochondria toincrease the production of ATP
Principles of	DC, powering semi-conductordiodes	DC, powering semi-conductordiodes	DC, powering semi-conductordiodes

Technological Characteristics Summary

The Erchonia® GVL (subject device) and the Erchonia® EVRL (predicate device) have identical principles of operation, power, energy source, energy delivery, mechanism of action, and treatment times. The only technological difference between the subject and the predicate device is substitution of a red laser diode with a green laser diode of identical power.

Performance Standards

The Erchonia® GVL Laser complies with FDA's performance standards for light-emitting products (21CFR 1040.10 and 21 CFR 1040.11 by Laser Notice #50).

Risk Assessment

The Erchonia® GVL, Model#: GVL is acceptable in accordance with IEC 60601 edition 3.1, by virtue of Engineering and third-party verification. All identified risks have been mitigated to ensure the lowest acceptable risk possible using the ISO 14971 standard framework.

Electromagnetic Compatibility and Electrical Safety

The Erchonia® GVL utilizes the same components as the predicate device, Erchonia® EVRL cleared under K191257, with the exception of the color of laser emission. The Erchonia® GVL emits violet/green light and the Erchonia® EVRL emits violet/red light, the change does not alter the safety and EMC testing previously conducted on the Erchonia® EVRL. Therefore, the safety and EMC testing which was conducted on the Erchonia® EVRL device (K191257) applies to the Erchonia® GVL. The device testing complies with the current IEC 60601-1, IEC 60601-2 and IEC 60825-1 standards. Furthermore, Erchonia has provided in this submission independent testing of the Erchonia GVL according to consensus standards.

Compliance with Voluntary Standards

The Erchonia® GVL complies with the following voluntary standards: IEC 60601-1-2:2014 IEC 60601-1:2005 (Third Edition) IEC 60825-1:2014 (Third Edition)

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Performance Testing-Clinical

Clinical Data

BACKGROUND: The purpose of this clinical study was to determine the effectiveness of the Erchonia® GVL, manufactured by Erchonia Corporation (the Company), when both the green and violet diodes are activated simultaneously, in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

STUDY DESIGN: The study was a single group non-inferiority design to evaluate equivalency or superiority of the Erchonia® GVL when applied in simultaneous green / violet dual diode mode to that of application of the Erchonia® EVRL when applied in simultaneous red / violet dual diode mode. The comparative data for the Erchonia® EVRL red / violet laser device was attained in the 2019 trial whose results successfully supported 510(k) clearance (K191257).

SUBJECTS: Forty-three (43) subjects completed the study.

STUDY PROCEDURES: Each subject received a single 13-minute active procedure administration with the Erchonia® GVL at the investigator's test site identical to the 2019 Erchonia® EVRL trial.

STUDY RESULTS: Study primary outcome measure was change in Visual Analog Scale (VAS) neck and shoulder pain rating from baseline to study endpoint evaluation. Individual subject success criteria was pre-established as a 30% or greater decrease in VAS rating at endpoint relative to baseline. The study was pre-established as a non-inferiority study of the Erchonia® GVL laser compared to the Erchonia® EVRL laser comparative data from the 2019 trial. Overall study success criteria was established as 75±5% of individual subject successes in the current trial.

Eighty-one-point four per cent (81.4%) of subjects in this study attained individual subject success compared with 75.0% of subjects treated in the 2019 Erchonia® EVRL trial.

The 37.77-point mean decrease (from 71.79 to 34.02) in neck and shoulder VAS pain rating from study Baseline to Endpoint for subjects in the current GVL study is comparable to the respective 29.80-point mean decrease for subjects in the 2019 EVRL study. T-test for correlated samples found the 37.77-point mean decrease for GVL study subjects to be statistically significant at p<0.0001.

Image /page/7/Figure/9 description: The image is a line graph titled "VAS Ratings Across Study Duration: GVL vs. EVRL". The x-axis represents the study duration, with labels for "Pre-Procedure", "Endpoint", "24 Hours Post", and "48 Hours Post". The y-axis represents the VAS ratings, ranging from 20 to 80. The graph compares the VAS ratings for GVL and EVRL over the study duration, with both lines showing a decrease in ratings over time.

Image /page/7/Figure/10 description: The image shows the title of a chart. The title is "Chart 1: Mean low back pain VAS ratings across study duration". The chart likely shows the mean low back pain VAS ratings over the course of a study.

ADVERSE EVENTS: No adverse event occurred for any subject throughout study duration.

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Substantially Equivalent Discussion

The Erchonia® GVL is substantially equivalent to the predicate device, the Erchonia® EVRL previously submitted under K191257. Both the subject device and the predicate device have identical principles of operation, power, energy source, energy delivery, mechanism of action, and treatment times. The only technological difference between the subject and the predicate device is the substitution of a red laser diode with a green laser diode of identical power, while the second diode consistently emits a violet wavelength in both devices. This difference 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 maintains extensive clinical data establishing safety and effectiveness for "providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin" with low level laser diodes in the visible light spectrum, including red laser diode only (K012580, K152196), red and violet laser diode (K191257), and green and violet laser diode (this submission). The clinical data provided in this submission demonstrates simultaneously administering the combination of green and violet diode yields comparable (equivalent) or better (superior) results with respect to decrease in subjects' neck and shoulder pain, while maintaining the same safety profile as the predicate device, Erchonia EVRL (K191257) while simultaneously administering red and violet diodes, and the reference device Erchonia EVRL (K152196, K012580) while administrating red laser only. (See Table 1)

Table 1: Individual Success Criteria Met: Subjects who met the study individual subject success criteria of a 30% or greater decrease in VAS neck and shoulder pain ratings from baseline to endpoint evaluation.

	Erchonia® GVL	Erchonia® EVRL	Erchonia® PL2000, Erchonia®EVRL
510(k) Number	Current Submission	K191257	K012580,K152196
Laser Diode	Green/ Violet	Red/ Violet	Red Only
n	43	44	43
n meeting success criteria	35	33	28
% Meeting success criteria	81.4%	75.0%	65.1%
Side Effects	None	None	None

Conclusion

Any differences between the subject device and predicate do not render the device not substantially equivalent, do not affect safety or effectiveness, or raise different questions of safety and effectiveness. Therefore, the Erchonia® GVL (subject device) is substantially equivalent to the Erchonia® EVRL (predicate device), indicated for use while using the green and violet diode simultaneously for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

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.