The InvisaRED™ Technology ELITE is indicated for use as a non-invasive dermatological aesthetic treatment for the temporary reduction of the circumference of waist, hips, and thighs through the process of photobiomodulation, affecting adipocyte cells within the adipose layer for the release of lipids from these cells.

Device Description

Device console:

Electrical Power: 110v
Cooling: Air Cooled
Operation: LCD touch screen
Allows Control of Individual Patient Session Protocol (Time, Energy, Pulse, Delay)
Integrated Device Power-On Self Test
Emergency Safety cut off switch
Treatment applicators (multi diode paddles) connected to the device console can number 8,10, or 12
Paddle Cooling: Air cooled
. Dual Coherent Frequencies: Thirteen (13) 680nm and thirteen (13) 980nm laser diodes on each paddle
Concurrent Laser Diode Mode of Operation: pulsed or continuous output
. Power output: Variable up to 200mw per diode for both 680nm and 980mm wavelengths

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criterion for the InvisaRED™ Technology ELITE, as inferred from the clinical study, is the demonstration of superiority over a sham device in temporarily reducing the circumference of the waist, hips, and thighs.

Acceptance Criteria (Primary Endpoint)	Reported Device Performance (Invisa-RED Elite)
Superiority to sham/placebo device in reducing measured body circumference (waist, hips, thighs)	An estimated mean difference of 6.880 inches greater loss when comparing the totals of the measured areas of subjects treated with the Invisa-RED Elite vs. the placebo device.
	95% confidence interval: 3.715 inches to 10.046 inches
	Two-tailed P value: < 0.001
Clinical Safety	No adverse effects or complications reported or observed during or subsequent to the trial.

Study Details

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

Sample Size: 40 subjects (35 female, 5 male).
Data Provenance: The document does not explicitly state the country of origin. It specifies that IR Technology LLC conducted the randomized double-blind study. It is a prospective study, as indicated by "conducted a randomized double blind study."

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

This information is not provided in the document. The ground truth appears to be objective measurements of body circumference rather than expert-derived assessments.

4. Adjudication method for the test set:

This information is not explicitly stated. Given that the primary endpoint is a direct measurement ("Change in Measured Body Circumference"), formal adjudication by experts may not have been deemed necessary in the same way it would be for subjective clinical assessments. The study was randomized and double-blind, which helps mitigate bias in data collection.

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:

No, this was not an MRMC comparative effectiveness study. This study evaluated a medical device (laser system) for aesthetic treatment, not an AI system assisting human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

Yes, in a sense, a standalone study was done. The "device" in question (Invisa-RED Elite) operates autonomously as a treatment device. The clinical study directly measured its effect on subjects compared to a sham device, without explicit human-in-the-loop interaction in the delivery of the treatment itself once initiated. The performance described is of the device on its own.

7. The type of ground truth used:

The ground truth used was objective outcomes data, specifically "Change in Measured Body Circumference" of the waist, hips, and thighs.

8. The sample size for the training set:

This information is not applicable/not provided. The Invisa-RED Elite is a physical device (a laser system), not an AI algorithm that requires a separate training set. The clinical study described is a validation study for the device's efficacy and safety.

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

This information is not applicable. As mentioned above, the device is not an AI algorithm requiring a training set with established ground truth.

Summary

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August 19, 2020

Image /page/0/Picture/1 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

IR Technology LLC % Thomas Namynanik Special Projects Consultant Vidantis Technologies, Inc 300 Lismore Terrace Woodstock, Georgia 30189

Re: K192275

Trade/Device Name: invisa-RED ELITE Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use Regulatory Class: Class II Product Code: OLI Dated: August 22, 2019 Received: August 22, 2019

Dear Thomas Namynanik:

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 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,

Colin Kejing Chen 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) K192275

Device Name InvisaRED™ Technology ELITE

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image is a logo for a company called "invisa-RED". The logo features a red square with the letters "iR" in white. The "R" is larger than the "i", and there is a trademark symbol to the right of the "R". Below the red square, the words "invisa-RED" are written in black.

6380 Bells Ferry Rd Acworth GA Suite 107 30102 (888) 221-7119

510(k) Summary

The assigned 510(k) Number: K199275

1. Date of Submission:

1. Sponsor
  IR Technology LLC 2707 Hampton TRL Woodstock GA 30189

Contact Person: Name: Stephen Reardon Title: Manager E-mail: Stephen Reardon info@invisaredtech.com Phone number: (888) 221-7119

3. Submission Correspondent

Thomas A Namynanik FDA Compliance Consultant 6380 Bells Ferry Rd Acworth GA Suite 107 30102 Tel: 404.915.5938 Email: andyn@invisaredtech.com

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Image /page/4/Picture/0 description: The image is a logo for "invisa-RED". The logo features a large, stylized "iR" in white against a red square. To the right of the "R" is a small "TM" symbol. Below the red square, the words "invisa-RED" are written in a sans-serif font, with "RED" in red and the rest in black.

Proposed Device Identification 4.

Proposed Device Name: invisa-REDTM Technology Elite Common/Usual Name: Fat Reducing Low Level Laser Classification: Class II Product Code: OLI Regulation Number: 21 CFR 878.5400 Review Panel: Division of Surgical Devices

ട. Predicate Device Identification

Primary Predicate:

510(k) Number: K130341 Product Name: Strawberry, Strawberry & Cream Manufacturer: LASER LIPO LIMITED

Secondary Predicates:

510(k) Number: K123237 Product Name: Zerona 2.0 Laser Manufacturer: ERCHONIA CORPORATION

510(k) Number: K143741 Product Name: Lipofina Laser System Manufacturer: YOLO Medical Inc.

510(k) Number: K160880 Product Name: Photonica Professional Manufacturer: WARD PHOTONICS LLC

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Image /page/5/Picture/0 description: The image is the logo for invisa-RED. The logo features a red square with a stylized white "iR" inside. The "R" is larger than the "i", and there is a "TM" symbol in the lower right corner of the "R". Below the red square, the words "invisa-RED" are written in black, with "invisa-" on the top line and "RED" on the bottom line.

6380 Bells Ferry Rd Acworth GA Suite 107 30102 Section 5 – Page 3 of 10 (888) 221-7119

Device Description 6.

Device console:

Electrical Power: 110v
Cooling: Air Cooled
Operation: LCD touch screen
Allows Control of Individual Patient Session Protocol (Time, Energy, Pulse, Delay)
Integrated Device Power-On Self Test
Emergency Safety cut off switch
Treatment applicators (multi diode paddles) connected to the device console can number 8,10, or 12
Paddle Cooling: Air cooled
. Dual Coherent Frequencies: Thirteen (13) 680nm and thirteen (13) 980nm laser diodes on each paddle
Concurrent Laser Diode Mode of Operation: pulsed or continuous output
. Power output: Variable up to 200mw per diode for both 680nm and 980mm wavelengths

What is invisa-RED™ Technology?

o A patented technology that uses laser diodes to propagate dual coherent laser frequencies of 980nm and 680nm into a patients dermal and adipose tissues for the reduction of the measured circumference of the patients waist, hips, and thighs.

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Image /page/6/Picture/0 description: The image is a logo for a company called "invisa-RED". The logo features a large, stylized "R" in white, set against a red square. The letters "i" and "R" are connected. Below the red square, the words "invisa-RED" are written in a smaller font, with "RED" in red and the rest in black.

How it works

0 The invisa-RED Elite laser diode paddles are secured to the exposed body area of the patient as prescribed for their treatment.
0 A patients specific protocol settings for power, pulse, delay and session length are set as prescribed.
The invisa-RED Elite's laser-diodes of 680mm and 980mm are energized and the 0 dermal and adipose tissues absorb photonic energy experiencing the effects of Photobiomodulation.
0 Note: The laser-diode paddle faces are designed with a surrounding raised lip in order to create an offset and air gap to prevent direct contact between the paddle surface and the patients skin.

Detail Science

· Photobiomodulation is defined as the utilization of non-ionizing electromagnetic energy to trigger photochemical changes within cellular structures which absorb photonic energy. The invisa-RED Elite uses concurrent Red and Near Infrared Laser Light for this purpose.
· Lipolysis is the metabolic process through which body fats are released into the interstitial space surrounding the cell, thereby reducing the size of the fat cells. It usually occurs in adipocytes cells which are specialized for the storage of fat.
• The invisa-RED Elite device induces lipolysis through Photobiomodulation in adipocyte cells releasing fat and creating the desired aesthetic of a reduced circumference of the treated body area.

Reference Articles:

Proposed Mechanisms of Photobiomodulation or Low-Level Light Therapy NCBI Lucas Freitas and Michael R Hamblin

The Nuts and Bolts of Low-level Laser (light) Therapy. Ann Biomed Eng. 2012 Feb;40(2):516-33. doi: 10.1007/s10439-011-0454-7. Epub 2011 Nov 2. PMID: 22045511; PMCID: PMC3288797. Chung H, Dai T, Sharma SK, Huang YY, Carroll JD, Hamblin MR.

Efficacy of low-level laser therapy for body contouring and spot fat reduction.

Caruso-Davis MK1, Guillot TS, Podichetty VK, Mashtalir N, Dhurandhar NV, Dubuisson O, Yu Y, Greenway FL.

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Image /page/7/Picture/0 description: The image features the logo for invisa-RED. The logo consists of a red square with the letters "iR" in white, with the "R" being larger and stylized. Below the square, the words "invisa-RED" are written in a sans-serif font, with "RED" in red and the rest in black.

7. Intended Use

The invisa-RED™ Technology Elite is indicated for use as a non-invasive aesthetic treatment for the temporary reduction of the circumference of waist, hips, and thighs through the process of photobiomodulation affecting adipocyte cells within the adipose layer for the release of lipids from these cells.

8. Non-Clinical Test Conclusion

Bench tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the following:

(a) IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Standards: IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012
(b) IEC 60601-2-22 Medical electrical equipment Part 2: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment - Standards: IEC 60601-2-22:2019 for use in conjunction with IEC 60601-1:2005, AMD1:2012
(c) IEC 60601-1:2005 + AMD 1:2012 US NATIONAL DIFFERENCES Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
(d) IEC 60825-1 Safety of Laser Products Part 1: Equipment Classification and Requirements - Standards: IEC 60825-1:2014 Ed. 3.0 and IEC 60825-1:2007 Ed. 2.0
(e) IEC 60601-1-2:2014
(f) Bio-compatibility Testing In Vitro Cytotoxicity Test of Diode laser paddle

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Image /page/8/Picture/0 description: The image is a logo for a company called "invisa-RED". The logo consists of a red square with the letters "iR" in white. The "R" is larger than the "i" and is placed to the right of the "i". The letters "TM" are in the bottom right corner of the red square. Below the red square is the word "invisa-RED" in black.

6380 Bells Ferry Rd Acworth GA Suite 107 30102 Section 5 - Page 6 of 10 (888) 221-7119

9. Randomized Double Blind Clinical Study

At the request of CDRH, IR Technology LLC conducted a randomized double blind study with a randomization ratio of 1:1.

The trial was undertaken with subjects comprised of 35 female subjects and 5 male subjects.

A null and alternative hypotheses was adopted for the primary trial endpoint "Change in Measured Body Circumference" as follows:

Ha : ut = uc where ut and uc represent the change in measured body H0 : ut = uc vs circumference of subjects treated by the invisa-Red Technology and the change in measured body circumference of subjects treated by the sham or placebo device.

Using an intent-to treat population, M=20 Imputations, an estimated mean difference of 6.880 inches greater loss was observed when comparing the totals of the measured areas of the subjects who underwent therapy using the invisa-RED Elite than with the placebo device. This with a 95% confidence interval from 3.715 inches to 10.046 inches and a two tailed P value < 0.001.

Based on the analysis performed the alternative hypothesis (Ha) for the superiority trial is affirmed for the primary endpoint (change in measured body circumference) as stated below:

Ha : µv + µc where µr and µc represent the change in measured body circumference of the trial subjects treated with the invisa-Red Technology and the change in measured body circumference of those treated with the sham device.

During the trial no adverse effects or complications as a result of the treatments were reported or observed for any trial subjects. Subsequent to the trial there have been no reports of subjects experiencing any adverse effects or complications.

Conclusion:

A conclusion therefore may be drawn that there is an interventional superiority of the invisa-RED Elite over the sham (placebo) device when employed for aesthetic therapy and that the invisa-RED Elite when used as directed is both clinically safe and effective when used to reduce the measured circumferences of a subjects waist, hips, and thighs.

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Image /page/9/Picture/0 description: The image is a logo for a company called "invisa-RED". The logo features a large, red square with a white "iR" inside. The "R" is much larger than the "i" and takes up most of the space inside the square. The letters "TM" are in the bottom right corner of the square. Below the square, the words "invisa-RED" are written in a smaller, sans-serif font.

Bells Ferry Rd Acworth GA Suite 107 30102 Section 5 – Page 7 of 10
0 221-7119

10. Technological Characteristics Comparison

The predicate devices cited below employ differing wavelengths of laser light. The invisa-RED ELITErw employs both Red and NIR laser light simultaneously at 680nm and 980nm, which is unique in the marketplace. Therefore in order to address questions of efficacy and safety raised by any technological difference we have included data from a clinical trial which has shown the invisa-RED ELITE™ to be both safe and effective when used as prescribed.

ITEM	Proposed Deviceinvisa-RED™ TechnologyELITE	Predicate DeviceZerona 2.0 Laser(K 123237)	Predicate DeviceStrawberry/Strawberry & Cream(K 130341)
ProductCode	OLI	OLI	OLI
RegulationNumber	21 CFR 878.5400	21 CFR 878.5400	21 CFR 878.5400
Class	II	II	II
IntendedUse	The invisa-RED™ TechnologyELITE is indicated for use as anon-invasive aesthetic treatmentfor the temporary reduction ofthe circumference of waist,hips, and thighs through theprocess of photobiomodulationaffecting adipocyte cells withinthe adipose layer for the releaseof lipids from these cells.	The Zerona 2.0 Laser isindicated for use as a non-invasive dermatologicalaesthetic treatment as anadjunct for individualsintending to undergoliposuction procedures forthe reduction ofcircumference of hips,waist and thighs.	The Strawberry/Strawberry &Cream is indicated for use as anon-invasive aesthetic treatmentfor the temporary reduction inwaist circumference by thedisruption of adipocyte cellswithin the fat layer for the releaseof fat and lipids from these cells.

Substantial Equivalence Comparison

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Image /page/10/Picture/0 description: The image contains the logo for invisa-RED. The logo features a red square with a large, white "iR" inside. The letters "invisa-RED" are written in lowercase below the square, with a dot separating the two words.

6380 Bells Ferry Rd Acworth GA Suite 107 30102 Section 5 – Page 8 of 10 (888) 221-7119

ITEM	Proposed Deviceinvisa-RED™ Technology	Predicate DeviceZerona 2.0 Laser(K 123237)	Predicate DeviceStrawberry/Strawberry & Cream(K 130341)
Enclosure	Plastic	Same	Same
Wavelength	680nm, 980nm	Green 532	660 +/- 15 nm
Waveform	Pulsed or continuous	Pulsed	Pulsed
Display	LCD	Same	Same
Power Supply	100-240 v ac 50-60 Hz	AC	100-240 v ac 50-60 Hz
Energy Source	200mw per diode	6 diodes, eachcollected then linedispersed androtated	Laser Diode from 660nm
Energy Delivery	Machine mounted probe	Same	Same
Paddles	6/8/10/12 pads areoptional	4-10	4/6/8/10
Pad Size	130X66mm	Similar	15.0 x 4.5 cm
Safety Features	Emergency Stop button - KeySwitch	Similar	Same
Cooling Requirements	Air cooled	Same	Same
Locations for Use	Hospital, healthcare provideroffice, MediSpas	Same	Same

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Image /page/11/Picture/0 description: The image is a logo for "invisa-RED". The logo features a large, stylized white "R" on a red square background, with the letters "i" and "R" connected. Below the square is the text "invisa-RED" in a smaller, sans-serif font, with "RED" in red and "invisa-" in black. There is a trademark symbol to the right of the "R" in the square.

6380 Bells Ferry Rd Acworth GA Suite 107 30102 Section 5 – Page 9 of 10
(888) 221-7110 (888) 221-7119

ITEM	Proposed Device	Predicate Device	Predicate Device
	invisa-RED™ Technology	Lipofina Laser System	Photonica Professional
	ELITE	(K 143741)	(K 160880)
ProductCode	OLI	OLI	OLI
RegulationNumber	21 CFR 878.5400	21 CFR 878.5400	21 CFR 878.5400
Class	II	II	II
IntendedUse	The invisa-RED™ TechnologyELITE is indicated for use as anon-invasive aesthetic treatmentfor the temporary reduction ofthe circumference of waist, hips,and thighs through the process ofphotobiomodulation affectingadipocyte cells within theadipose layer for the release oflipids from these cells.	The Lipofina Laser Systemis indicated for non-invasive aesthetictreatment for thetemporary reduction ofcircumference of hips..	The Photonica Professional isindicated for use as a non-invasive aesthetic treatment forthe temporary reduction of hips,waist and thighs.
Enclosure	Plastic	Same	Same
Wavelength	680nm, 980nm	658 (central)	635 +/- 2 nm
Waveform	Pulsed or continuous	Pulsed	Pulsed
Display	LCD	Same	Same
PowerSupply	100-240 v ac 50-60 Hz	100-240 v ac 50-60 Hz	100-240 v ac 50-60 Hz
EnergySource	200mW each for Laser Diodesboth 680nm and 980nm	35mW/diode	Laser Diode from 105mW/cm2
EnergyDelivery	Machine mounted paddle	Same	Same
Paddles	6/8/10/12 pads are optional	12	Similar
Pad Size	130X66mm	Similar	Similar
SafetyFeatures	Emergency Stop button - KeySwitch	Similar	Same
CoolingRequirements	Air cooled	Same	Same
Locationsfor Use	Hospital, healthcare provideroffice, MediSpas	Same	Same

Substantial Equivalence Comparison Con't

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Image /page/12/Picture/0 description: The image is a logo for invisa-RED. The logo consists of a red square with a white "iR" inside. The "R" is larger than the "i". Below the square is the word "invisa-RED" in black, with a hyphen between "invisa" and "RED".

6380 Bells Ferry Rd Acworth GA Suite 107 30102 Section 5 – Page 10 of 10 (888) 221-7119

11. Substantially Equivalent Conclusion

Based on both clinical trial results and comparative analysis of the intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, and standards, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

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.