invisa-RED ELITE

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192275 Device Name InvisaRED™ Technology ELITE #### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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: - 2. 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ 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. {6}------------------------------------------------ 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. {7}------------------------------------------------ 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 {8}------------------------------------------------ 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. {9}------------------------------------------------ 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 Device<br>invisa-RED™ Technology<br>ELITE | Predicate Device<br>Zerona 2.0 Laser<br>(K 123237) | Predicate Device<br>Strawberry/Strawberry & Cream<br>(K 130341) | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product<br>Code | OLI | OLI | OLI | | Regulation<br>Number | 21 CFR 878.5400 | 21 CFR 878.5400 | 21 CFR 878.5400 | | Class | II | II | II | | Intended<br>Use | The invisa-RED™ Technology<br>ELITE is indicated for use as a<br>non-invasive aesthetic treatment<br>for the temporary reduction of<br>the circumference of waist,<br>hips, and thighs through the<br>process of photobiomodulation<br>affecting adipocyte cells within<br>the adipose layer for the release<br>of lipids from these cells. | The Zerona 2.0 Laser is<br>indicated for use as a non-<br>invasive dermatological<br>aesthetic treatment as an<br>adjunct for individuals<br>intending to undergo<br>liposuction procedures for<br>the reduction of<br>circumference of hips,<br>waist and thighs. | The Strawberry/Strawberry &<br>Cream is indicated for use as a<br>non-invasive aesthetic treatment<br>for the temporary reduction in<br>waist circumference by the<br>disruption of adipocyte cells<br>within the fat layer for the release<br>of fat and lipids from these cells. | #### Substantial Equivalence Comparison {10}------------------------------------------------ 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 Device<br>invisa-RED™ Technology | Predicate Device<br>Zerona 2.0 Laser<br>(K 123237) | Predicate Device<br>Strawberry/Strawberry & Cream<br>(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, each<br>collected then line<br>dispersed and<br>rotated | Laser Diode from 660nm | | Energy Delivery | Machine mounted probe | Same | Same | | Paddles | 6/8/10/12 pads are<br>optional | 4-10 | 4/6/8/10 | | Pad Size | 130X66mm | Similar | 15.0 x 4.5 cm | | Safety Features | Emergency Stop button - Key<br>Switch | Similar | Same | | Cooling Requirements | Air cooled | Same | Same | | Locations for Use | Hospital, healthcare provider<br>office, MediSpas | Same | Same | {11}------------------------------------------------ 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) | | Product<br>Code | OLI | OLI | OLI | | Regulation<br>Number | 21 CFR 878.5400 | 21 CFR 878.5400 | 21 CFR 878.5400 | | Class | II | II | II | | Intended<br>Use | The invisa-RED™ Technology<br>ELITE is indicated for use as a<br>non-invasive aesthetic treatment<br>for the temporary reduction of<br>the circumference of waist, hips,<br>and thighs through the process of<br>photobiomodulation affecting<br>adipocyte cells within the<br>adipose layer for the release of<br>lipids from these cells. | The Lipofina Laser System<br>is indicated for non-<br>invasive aesthetic<br>treatment for the<br>temporary reduction of<br>circumference of hips.<br>. | The Photonica Professional is<br>indicated for use as a non-<br>invasive aesthetic treatment for<br>the temporary reduction of hips,<br>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 | | Power<br>Supply | 100-240 v ac 50-60 Hz | 100-240 v ac 50-60 Hz | 100-240 v ac 50-60 Hz | | Energy<br>Source | 200mW each for Laser Diodes<br>both 680nm and 980nm | 35mW/diode | Laser Diode from 105mW/cm2 | | Energy<br>Delivery | Machine mounted paddle | Same | Same | | Paddles | 6/8/10/12 pads are optional | 12 | Similar | | Pad Size | 130X66mm | Similar | Similar | | Safety<br>Features | Emergency Stop button - Key<br>Switch | Similar | Same | | Cooling<br>Requiremen<br>ts | Air cooled | Same | Same | | Locations<br>for Use | Hospital, healthcare provider<br>office, MediSpas | Same | Same | # Substantial Equivalence Comparison Con't {12}------------------------------------------------ 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.