Contour Light CL-100

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May 19, 2021 Contour Research, LLC % Shepard Bentley Consultant Bentley Biomedical Consulting, LLC 28241 Crown Valley Parkway, Suite 510(k) Laguna Niguel, California 92677 Re: K202955 Trade/Device Name: Contour Light CL-100 Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use 878.5650 Regulatory Class: Class II Product Code: OLI Dated: September 29, 2020 Received: September 30, 2020 Dear Shepard Bentley: 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. {1}------------------------------------------------ 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 devices or post-marketing 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. Purva Pandya 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}------------------------------------------------ # DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K202955 Device Name Contour Light CL-100 Indications for Use (Describe) The Contour Light CL-100 device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The Contour Light CL-100 device is indicated to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle spasm, and pain and stiffness associated with arthritis, for promoting relaxation of the muscle tissue, and to temporarily increase local blood circulation. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over -The-Counter Use (Part 21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies on to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW* The burden time for this collection of information is estimated to average 79 hours per response, including the Time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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 many 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." FORM FDA 3881 (7/17) {3}------------------------------------------------ # 510(k) Summary # Contour Light CL-100 #### 1. Submission Sponsor Contour Research, LLC 200 Virginia Street, #8 Reno, NV 89501 Doug Dreier CEO Cell: 949 939 7584 Office: 855 932 6686 doug@contourlight.com ### 2. Submission Correspondent Shepard G. Bentley, RAC 28241 Crown Valley Parkway Suite 510(k) Laguna Niguel, CA 92677 949 374 9187 sbentley@bentleybiomed.com ## 3. Date Prepared 29 SEPT 2020 ## 4. Device Identification | Trade or Proprietary Name: | Contour Light CL-100 | |----------------------------|-----------------------------------------------------------| | Common or Usual Name: | Low Level Light System for Aesthetic Use<br>Infrared Lamp | | Regulation Number: | 21 CFR §878.5400<br>21 CFR §890.5500 | | Product Codes: | OLI, ILY | | Class: | II | {4}------------------------------------------------ #### Legally Marketed Predicate Device(s) | Device name: | Strawberry and Cream Low Level Laser system | |----------------|---------------------------------------------| | 510(k) number: | K130341 | | Manufacturer: | Laser Lipo Ltd | | Device name: | Zerona Z6 OTC | | 510(k) number: | K143007 | | Manufacturer: | Erchonia Corporation | | Device name: | BioPhotas LifeLight | | 510(k) number: | K122237 | | Manufacturer: | BioPhotas, Inc. | #### 5. Indication for Use Statement The Contour Light CL-100 is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The Contour Light CL-100 is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. #### 6. Device Description The Contour Light CL-100 is a low level laser (red light LED) system that applies 635nm light for the purpose of reducing the circumference of the hips, waist and thighs for aesthetic benefit, and 630nm light for the purpose of temporarily elevating skin temperature. The Contour Research, LLC Contour Light CL-100 device applies a light emitting diode (LED) technology, and is used to perform red light LED-based circumferential reduction of the hips, thighs and waist in adults, or red light and IR LEDs for temporary elevation of skin temperature, within a treatment time of 30 minutes. The device is comprised of a panel of LEDs that is adjustable to conform generally to the outer dimensions of the individual being treated, a software controlled console that is used to select and maintain the application of the LED light, a power adaptor, and cables that connect to the energy source. The device is powered by connecting it to an 85-264 VAC, at 3 amps, 47-63 Hz. power source. #### Operator Controls: The device is controlled by an operator. The operator controls include additional safety measures including an EMERGENCY STOP button. If activated, the Emergency Stop halts the program and shuts off the power that is delivering the LED light to the individual being treated. {5}------------------------------------------------ # 7. Substantial Equivalence Discussion The following table compares the Contour Light CL-100 with the predicate devices. | Table 5A - Comparison of Characteristics | | |------------------------------------------|--| |------------------------------------------|--| | Attribute | Subject Device | Predicate Device | Predicate Device | Predicate Device | Comparison | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Contour Research, LLC | Lipo Laser Ltd | Erchonia Corporation | BioPhotas, Inc. | | | Trade Name | Contour Light CL-100 | Strawberry and<br>Cream Low Level<br>Laser system | Zerona Z6 OTC | LifeLight | | | 510(k) Number | K202955 | K130341 | K143007 | K122237 | | | Product Code | OLI, ILY | OLI | OLI | ILY | Comparable | | Regulation Number | §878.5400, §890.5500 | §878.5400 | §878.5400 | §890.5500 | Comparable | | | | Clinical/Design Features | | | | | Indications for Use | The Contour Light CL-<br>100 is indicated for<br>use as a non-invasive<br>dermatological<br>aesthetic treatment<br>for the reduction of<br>circumference of hips,<br>waist, and thighs.<br>The Contour Light CL-<br>100 device is intended<br>to deliver heat in the<br>IR spectrum to<br>provide topical | The low level laser<br>model Strawberry<br>and Strawberry and<br>Cream can be used<br>for the non-invasive<br>temporary reduction<br>in waist<br>circumference by the<br>disruption of<br>adipocyte cells<br>within the fat layer<br>for the release of fat<br>and lipids from these<br>cells for non-invasive<br>aesthetic use. | The Zerona® Z6 OTC<br>device is indicated for<br>use as a non-invasive<br>dermatological aesthetic<br>treatment for the<br>reduction of<br>circumference of hips,<br>waist, and thighs. | The BioPhotas<br>LifeLight device is<br>intended to<br>deliver heat in the<br>IR spectrum to<br>provide topical<br>heating for the<br>purpose of<br>elevating tissue<br>temperature; for<br>the temporary<br>relief of minor<br>muscle and joint | The subject device<br>indication for use is<br>essentially identical<br>to the first<br>indication for use<br>of the Zerona®<br>predicate device,<br>and essentially<br>identical to the first<br>indication for use<br>of the IR predicate<br>device (LifeLight). | | | heating for the<br>purpose of elevating<br>tissue temperature;<br>for the temporary<br>relief of minor muscle<br>and joint pain,<br>arthritis and muscle<br>spasm; relieving<br>stiffness; promoting<br>the relaxation of<br>muscle tissue; and to<br>temporarily increase<br>local blood<br>circulation. | | | pain, arthritis and<br>muscle spasm;<br>relieving stiffness;<br>promoting the<br>relaxation of<br>muscle tissue; and<br>to temporarily<br>increase local<br>blood circulation.<br>The blue<br>spectrum light is<br>intended to<br>reduce the<br>appearance of<br>mild to moderate<br>acne vulgaris. | | | Non-invasive? | Yes | Yes | Yes | Yes | Same | | Lamp Specifications | | | | | | | Wavelength | 635nm<br>880nm | 660nm | 635nm | 464nm, 640nm,<br>880nm | Similar | | Output<br>Intensity/Irradiance<br>(mW/cm²) | 4.1mW/cm²<br>0.5mW/cm² | 5-10mW/cm² | <1mW/cm² | 10.9 mW/cm² for<br>465nm | Similar | | Recommended<br>Treatment Time<br>(Minutes) | 30 minutes | 10 – 20 minutes | 0-9.9 minutes | 30 minutes | Similar | {6}------------------------------------------------ {7}------------------------------------------------ ### 8. Non-Clinical Performance Data To demonstrate the safety and effectiveness of Contour Light CL-100 device and to show substantial equivalence to the predicate devices, Contour Research, LLC completed the following non-clinical tests. Results confirm that the design and performance specifications for the device are met. Reports as applicable are filed with their respective sections. The Contour Light CL-100 passed test requirements as identified below: - Electrical safety testing per IEC 60601-1 - Passed - Electromagnetic Disturbance testing per IEC 60601-1-2 – Passed - Software verification and validation per IEC 62304/FDA Guidance - Completed. - Shelf Life Testing Supports useful device life of 5 years ● - Internal Design Validation Testing #### 9. Clinical Performance Data None submitted. ### 10. Conclusions The Contour Research, LLC Contour Light CL-100 device has an intended use with red light that is essentially identical to the K130341 and K143007 devices' first intended use, and it also has an intended use that is essentially identical to the K122237 predicate device's intended use with infrared light. The proposed device and its predicates share similar technological characteristics for achieving the desired effects, and the minor differences in technological characteristics do not raise new types of questions regarding safety and effectiveness for its indications for use. Performance testing has demonstrated the Contour Light CL-100 is as safe and effective as the predicate devices. Therefore, the Contour Light CL-100 device is substantially equivalent to the predicate devices.