The Erchonia® Emerald (Model # SHL) Laser is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference in individuals with a Body Mass Index (BMI) up to 40 kg/m².

Device Description

The Erchonia® Emerald (Model#: SHL) is low-level laser system that uses ten (10) semi-conductor diodes (visible green-light) 522nm to 542nm. The Erchonia® Emerald (Model#: SHL) has been classified by the FDA as a Class II device and a Class II Laser in accordance with IEC 60825-1 (Complies with 21 CFR 1040.10 and 21 CFR 1040.11 by laser notice #50. The performance parameters and intended use of the Erchonia® Emerald (Model#: SHL) are compliant to the internationally recognized safety testing standards for medical devices. The Erchonia® Emerald (Model#: SHL) device includes functional performance, electrical, safety and component verification, in accordance with the FDA QS requirement, validated annually through ISO 13485 and MDSAP audits. The software incorporated into the operation of the Erchonia® Emerald (Model#: SHL) complies with FDA and ISO Software Development and Validation regulations.

The components of the device include a mobile base that plugs into the wall, using a hospital grade power cord, equipped with a medical-grade transformer. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to mains power. Four (4) antistatic wheels that enable ease for maneuverability. A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The laser diodes can only be on or off; there is no user interface that allows the end-user to alter the laser diode output. The protocol is factory set and cannot be altered by the end-user. The device has an adjustable main arm that is attached to the mobile base with the laser head assembly located at the laser head assembly that is attached to the adjustable main arm utilizes internal mechanics that collects the light emitted from each of the ten (10) laser diodes that rotate in a spiraling circle pattern that is totally random and independent of the other diodes. The laser head assembly can be manually adjusted for positioning the lasers 3-4 inches from the patient's skin to deliver treatment for body contouring. The device laser head assembly can be moved vertically (raised or lowered) over the subject for proper height placement of lasers for treatment. The device laser head assembly can be moved horizontally (left or right) over the patient for proper placement of lasers for treatment. The device laser head assembly has two adjustable outside laser arms with each arm housing two (2) laser diodes that can be moved in and out for proper positioning to the patient for accurate treatment distance.

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.

AI/ML Overview

The provided text describes the Erchonia Emerald (Model # SHL) Laser, a low-level laser system intended for non-invasive dermatological aesthetic treatment for the reduction of body circumference in individuals with a Body Mass Index (BMI) up to 40 kg/m².

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Erchonia Emerald Laser are based on its substantial equivalence to predicate devices, which were proven safe and effective through clinical trials. The reported device performance is therefore inferred from the performance of these predicate devices.

Acceptance Criteria (based on predicate device performance)	Reported Device Performance (Erchonia® Emerald Laser)
Non-invasive dermatological aesthetic treatment for reduction of body circumference in individuals with BMI between 30 and 40 kg/m² (from primary predicate Erchonia SHL Laser K142042)	Indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference in individuals with a Body Mass Index (BMI) up to 40 kg/m² (Broader BMI range, but performance is based on the substantial equivalence principle and shared physiological mechanism).
Safety and effectiveness in providing this treatment.	The physiological mechanism of action provided by the Erchonia Corporation 532nm diode laser has demonstrated safety and effectiveness to support the proposed indication of use based on equivalent predicate device(s).
Total light energy delivered per treatment: 288 J	Total Joules Per Treatment: 288 J
Wavelength: 522nm to 542nm	Wavelength: 522nm to 542nm
Power (measured at aperture) per diode: 16mW ± 2mW	Power (measured at aperture) per diode: 16mW ± 2mW
Treatment time: 0-30 minutes	Treatment time: 0-30 minutes

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

The submission explicitly states: "Erchonia Corporation did not perform a clinical study for the indication for use proposed in this premarket notification. Substantial equivalence is based on the primary predicate device, the Erchonia® SHL Laser (Model# SHL) K142042, as well as the secondary predicate device, the Erchonia® Zerona™ 2.0 Laser (Model# GLS) K123237."

Therefore, there is no new test set data generated for the Erchonia Emerald device itself to directly prove its acceptance criteria. The data provenance is from the clinical trials conducted for the predicate devices. The document does not specify the sample sizes or country of origin for the predicate device studies.

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

Since no new clinical study was conducted for the Erchonia Emerald, this information is not available in the provided text. The ground truth for the predicate devices' clinical trials would have been established by clinical outcomes and measurements, typically interpreted by qualified medical professionals.

4. Adjudication Method for the Test Set

As no new clinical study was performed for the Erchonia Emerald, there's no adjudication method described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done for the Erchonia Emerald Laser as no new clinical study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a physical laser system, not an algorithm, so the concept of a "standalone algorithm" performance study is not applicable.

7. Type of Ground Truth Used

The ground truth for the performance claims is based on the clinical outcomes data from the clinical trials performed for the predicate devices (Erchonia® SHL Laser K142042 and Erchonia® Zerona™ 2.0 Laser K123237). These trials demonstrated the safety and effectiveness of those devices in reducing body circumference.

8. Sample Size for the Training Set

As this is a physical medical device and not an AI/ML algorithm that requires a "training set" in the computational sense, this concept is not applicable. The device's design and operation are based on established scientific principles of low-level laser therapy and its equivalence to previously cleared devices.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this device. The efficacy and safety are established via substantial equivalence to predicate devices that underwent clinical trials.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

Erchonia Corporation Mr. Steven Shanks President 650 Atlantis Road Melbourne, Florida 32904

Re: K192544

Trade/Device Name: Erchonia Emerald Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use Regulatory Class: Class II Product Code: OLI Dated: September 13, 2019 Received: September 16, 2019

Dear Steven Shanks:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Mavadia-Shukla 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) K192544

Device Name Erchonia Corporation

Indications for Use (Describe)

Erchonia® Emerald (Model # SHL) Laser is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference in individuals with a Body Mass Index (BMI) up to 40 kg/m².

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K 192544 --- 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Owner Information

Name and Address of Sponsor / Manufacturer

Erchonia Corporation 650 Atlantis Rd. Melbourne, FL. 32904 Telephone: 321-473-1251 Fax: 321-473-1608

Establishment Registration Number 2032513

Name and Address of Official Correspondent

Erchonia Corporation 650 Atlantis Road Melbourne, FL 32904 Contact: Mr. Steven Shanks Telephone: 321-473-1251 Fax: 321-473-1608 Email: sshanks@erchonia.com

Date Prepared

01/10/2020

Device Information

Trade Name: Erchonia® Emerald Laser Model#: SHL Common Name: Fat Reducing Low-Level Laser Classification Name: Low-level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use. (21 CFR 878.5400) Classification: Class II Panel: General & Plastic Surgery Product Code: OLI

Predicate Device

The Erchonia® Emerald Laser (Model#: SHL) is substantially equivalent to the primary predicate device, the Erchonia® SHL Laser (Model# SHL) K142042. Additionally, the Erchonia® Emerald Laser (Model#: SHL) is substantially equivalent to the secondary predicate device, the Erchonia® Zerona™ 2.0 Laser (Model# GLS) K123237.

The principles of operation of the Erchonia® Emerald Laser (Model#: SHL) are identical to the previously cleared Erchonia® SHL Laser (Model# SHL) with the exception of a design change.

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Reference Device

As part of this 510(k) submission, there is a reference device, which is the Erchonia® Zerona Z6 (Model# SHR) K162578.

The use of the reference device is rationalized as it points to a previous 510(k) application in which an FDA market clearance was granted for overall body contouring with another Erchonia Corporation device (Erchonia® Zerona Z6) that has the same intended use as the subject device; "the non-invasive reduction in fat laver for body contouring."

Device Description

The associated accessories include:

Device Accessories:

Laser safety glasses (1) Patient & (1) Operator -
-Tape measure
Manual -
Power cord -

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Assembly Accessories:

Large Screws (2) -
-1/8 (Large) Allen Driver
-Small Screws (4)
1/16 (Small) Allen Driver -
-Wire Cover
Arm Cover -

Intended Use / Indications for Use

Design Change

The principles of operation of the Erchonia® Emerald (Model# SHL) are identical to the primary predicate device, Erchonia® SHL Laser (Model# SHL), with the exception of a design change. Below is a table that details the comparison of the technology between the subject device and the primary predicate device.

Erchonia® SHL (K142042)	Erchonia® Emerald	Changes
Materials: Kydex T ABS, Acetal,6061-T6 AL Aluminum	Materials: PT8952 Polyurethane,Kydex T ABS, Acetal, 6061-T6 ALAluminum, 5052 Aluminum	Device enclosure:updated appearance
The main arm, or boom arm,adjustment mechanism isdesigned using spring tension.The adjustment of the main arm isby manual movement from theend user. This allows the end userto lower and raise the LaserOutput Heads for properpositioning to patient for accuratetreatment distance.The device is also designed withan arm lock to manually lock themain arm adjustment in place.	The main arm adjustment mechanismis designed using an electric motor(arm motor). The adjustment of themain arm is performed by the end usermoving the device arm control switch(this powers the arm motor). Thisallows the end user to lower and raisethe Laser Output Heads for properpositioning to patient for accuratetreatment distance.Once a protocol has ended the mainarm will automatically raise up andaway from the patient.	Main arm heightadjustment mechanism:electric motor withcontrol switch
Boom Arm: Surgi-Med Solutions- EM 0908.1Arm Lock (provided w/ BoomArm)	Arm Motor: Mcmaster - 6409K18Control Switch: C&K -7205J61ZQE22
Erchonia® SHL (K142042)	Erchonia® Emerald	Changes
The PLC & touchscreen are offthe shelf components.The device has an 8" touchscreen.	The PLC (also known as PCB) is acustom component, designedspecifically for Erchonia. Thetouchscreen is off the shelf.	PLC & touchscreen:
PLC: Automation Direct - DL-205 PLC/D2-06BDC1-1, DL-250-1, F2-16TD2P, H2-CTRIOTouchscreen: Automation Direct- EA9-T8	The device has an 10.4" touchscreen.PLC: Communication SystemsSolutions - ERCSS4/HPS2 MainPCB/ER-E-00302Touchscreen: NLT Technologies -NL10276BC20-18BD, PTPW10	custom PLC & largertouchscreen
PSU: Condor/SL Power -MINT3110A1908K01	PSU: Condor/SL Power -MINT3110A0508K01	AC to DC power supply(PSU):a different PSU isrequired for powerdemands of arm motor,updated PLC & updatedtouchscreen
Device is designed with amechanical key-switch with aremovable key. The key must beinserted into the key-switch andturned to the ON position tooperate the lasers.	Device is designed with 4 digitpasscode within device software. Thecorrect 4 digit passcode must beentered into the device software viathe touchscreen to operate the lasers.	Device lockoutmechanism:passcode withinsoftware
Erchonia® SHL (K142042)	Erchonia® Emerald	Areas that RemainUnchanged
10	10	Quantity of diodes perdevice
16mW ± 2mW	16mW ± 2mW	Power (measured ataperture) per diode
522nm to 542nm	522nm to 542nm	Wavelength
Multi diode collected then linedispersed (coherent)	Multi diode collected then linedispersed (coherent)	Energy Source
0 - 30 minutes	0 - 30 minutes	Treatment time
288 J	288 J	Total Joules PerTreatment

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Comparison of Technological Characteristics with the Predicate Device(s)

The principles of operation of the Erchonia® Emerald Laser (Model#: SHL) are identical to the previously cleared Erchonia® SHL Laser (Model# SHL) with the exception of a design change that was detailed above.

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Device	Erchonia® Emerald Laser(Model# SHL)	Erchonia® SHL Laser(Model# SHL)	Erchonia® Zerona 2.0(Model# GLS)	Erchonia® Zerona Z6(Model# SHR)
510(k) #	Unknown	K142042	K123237	K162578
	Subject Device	Primary Predicate	Secondary Predicate	Reference Device
Power (measured at aperture)	16mW ± 2mW	16mW ± 2mW	16mW ± 2mW	17.25mW ± 1.25mW
Wavelength	522nm to 542nm	522nm to 542nm	522nm to 542nm	630nm to 650nm
Energy Source	Multi diode collected then linedispersed (coherent)	Multi diode collected then linedispersed (coherent)	Multi diode collected then linedispersed (coherent)	Multi diode collected then linedispersed (coherent)
Treatment time	0 - 30 minutes	0 - 30 minutes	0 - 30 minutes	0 - 40 minutes
Total Joules PerTreatment	288 J	288 J	173 J	248 J
Power Supply	100-240VAC, 50-60Hzelectrical outlet	100-240VAC, 50-60Hzelectrical outlet	100-240VAC, 50-60Hzelectrical outlet	100-240VAC, 50-60Hzelectrical outlet
Energy Delivery	Floor model device with probehead	Floor model device with probehead	Floor model device with probehead	Floor model device with probehead
Target Size per diode	Line pattern, electronicallyscanned over area of treatment	Line pattern, electronicallyscanned over area of treatment	Line pattern, electronicallyscanned over area of treatment	Line pattern, electronicallyscanned over area of treatment
Indication for Use	The Erchonia® Emerald(Model#: SHL) Laser isindicated for use as a non-invasive dermatologicalaesthetic treatment for thereduction of bodycircumference in individualswith a Body Mass Index (BMI)up to 40 kg/m²	The Erchonia® SHL Laser isindicated for use as a non-invasive dermatologicalaesthetic treatment for reductionof circumference of hips, waistand upper abdomen whenapplied to individuals with aBody Mass Index (BMI)between 30 kg/m² and 40 kg/m²	The Erchonia® Zerona™ 2.0Laser is indicated for use as anon-invasive dermatologicalaesthetic treatment as an adjunctfor individuals intending toundergo liposuction proceduresfor the reductions ofcircumference of hips, waist,and thighs	The Zerona Z6 Laser isindicated for us as a non-invasive dermatologicalaesthetic treatment for thereduction of bodycircumference
Product Code	OLI	OLI	OLI	OLI
Principles ofOperation	Mains power, converted to DC,powering semi-conductordiodes	Mains power, converted to DC,powering semi-conductordiodes	Mains power, converted to DC,powering semi-conductordiodes	Mains power, converted to DC,powering semi-conductordiodes

Comparison of Technological Characteristics with the Predicate Device(s)

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Performance Data

Compliance with Voluntary Standards

The device complies with the following standards:

Medical electrical equipment - Part 1: General Requirements for Basic Safety and Essential Performance IEC 60601-1:2005 3rd Edition,

General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests IEC 60601-1-2:2014 4th Edition, and

Safety of Laser Products IEC/EN 60825-1:2007 2™ Edition

Performance Standards

The device complies with the FDA's performance standards for light-emitting products (21 CFR 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. As an electromechanical device containing no biodegradable materials, such as chemical or biologic, and no mechanical componentry subject to degradation, such as batteries, the aging rationale is based on only the acceptable transportation parameters of time and conditions. The transportation range was assessed by evaluating each component's acceptable temperature and humidity parameters, then identifying an all-inclusive high-low spread. The range noted in the Erchonia® Emerald (Model#: SHL) Owner's Manual was considered and determined acceptable as part of the IEC 60601-1 Safety Testing and is in compliance with the FDA guidance document "Shelf-Life of Medical Devices."

Software Verification and Validation Testing

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 Contained in Medical Devices." The software for this device was considered a "minor" level of concern.

Clinical Data

Erchonia Corporation did not perform a clinical study for the indication for use proposed in this premarket notification. Substantial equivalence is based on the primary predicate device, the Erchonia® SHL Laser (Model# SHL) K142042, as well as the secondary predicate device, the Erchonia® Zerona™ 2.0 Laser (Model# GLS) K123237.

Conclusion

Any technological differences between the subject device and predicate do not render the device not substantially equivalent, do not affect the safety or effectiveness, or raise questions regarding the safety and effectiveness due to the fact the total light energy delivered per treatment is equivalent to the predicate(s). The new and predicate device(s) have equivalent technology and provides the same wavelength. The predicate device(s) treatment protocols went through clinical trials to demonstrate that

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they are safe and effective in providing a non-invasive dermatological aesthetic treatment for the reduction of body circumference in individuals with a Body Mass Index (BMI) up to 40 kg/m²

Therefore, based on the equivalent predicate device(s), the physiological mechanism of action provided by the Erchonia Corporation 532nm diode laser has demonstrated safety and effectiveness to support the proposed indication of use "as a non-invasive dermatological aesthetic treatment for the reduction of body circumference in individuals with a Body Mass Index (BMI) of up to 40 kg/m²."

Regulation Number and Section

§ 878.5400 Low level laser system for aesthetic use

(a)
Identification. A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.