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.

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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Contour Light CL-100". It focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study.

Therefore, the information required to answer your request (acceptance criteria, details of a study proving the device meets acceptance criteria, sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is largely absent from this document.

This 510(k) summary explicitly states:

"9. Clinical Performance Data: None submitted." (Page 7)

This means no clinical study was conducted or submitted as part of this 510(k) application to demonstrate the device's performance against pre-defined acceptance criteria. The basis for clearance is substantial equivalence to predicate devices, supported by non-clinical performance data (electrical safety, EMC, software, shelf life, internal design validation).

However, I can extract the following relevant, albeit limited, information:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly defined in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, or quantifiable reduction in circumference). The "acceptance criteria" for this 510(k) revolved around demonstrating substantial equivalence in intended use and technological characteristics to legally marketed predicate devices, and passing non-clinical safety tests.
Reported Device Performance:
- The device passed Electrical safety testing per IEC 60601-1.
- The device passed Electromagnetic Disturbance testing per IEC 60601-1-2.
- Software verification and validation per IEC 62304/FDA Guidance were Completed.
- Shelf Life Testing Supports useful device life of 5 years.
- Internal Design Validation Testing results were also mentioned (no specific metrics provided).

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

Sample Size: Not applicable. No clinical test set data was submitted.
Data Provenance: Not applicable.

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

Not applicable. No clinical test set and thus no expert ground truth establishment method was described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

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 MRMC study was done, as no clinical data was submitted. The device is a "Low Level Laser System For Aesthetic Use" and "Infrared Lamp," not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. No clinical ground truth was established, as no clinical study was performed or submitted.

8. The sample size for the training set:

Not applicable. There is no indication of machine learning or deep learning models being trained with a training set for this device.

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

Not applicable.

Summary of what the document does describe as the basis for clearance:

The device (Contour Light CL-100) was cleared based on its substantial equivalence to predicate devices (Strawberry and Cream Low Level Laser system, Zerona Z6 OTC, BioPhotas LifeLight). This equivalence was argued through:

Identical/Similar Indications for Use: The Contour Light CL-100's indications for reducing circumference of hips, waist, and thighs, and topical heating for pain relief and circulation, are presented as essentially identical to those of the predicate devices.
Similar Technological Characteristics: All devices are low-level light/laser systems for aesthetic use and/or pain relief. Minor differences in wavelength and intensity were deemed not to raise new safety or effectiveness concerns.
Non-Clinical Performance Data: As listed in point 1, the device successfully completed various safety and performance tests (electrical safety, EMC, software validation, shelf life, internal design validation).

This 510(k) submission chose a pathway that did not require a clinical study demonstrating performance against specific quantitative acceptance criteria on human subjects, relying instead on the established safety and effectiveness of the predicate devices and the non-clinical testing of the subject device.

Summary

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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.

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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

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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.

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.

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unless it displays a currently valid OMB number."

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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 UseInfrared Lamp
Regulation Number:	21 CFR §878.540021 CFR §890.5500
Product Codes:	OLI, ILY
Class:	II

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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

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.

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7. Substantial Equivalence Discussion

The following table compares the Contour Light CL-100 with the predicate devices.

Table 5A - Comparison of Characteristics
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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 andCream Low LevelLaser 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-100 is indicated foruse as a non-invasivedermatologicalaesthetic treatmentfor the reduction ofcircumference of hips,waist, and thighs.The Contour Light CL-100 device is intendedto deliver heat in theIR spectrum toprovide topical	The low level lasermodel Strawberryand Strawberry andCream can be usedfor the non-invasivetemporary reductionin waistcircumference by thedisruption ofadipocyte cellswithin the fat layerfor the release of fatand lipids from thesecells for non-invasiveaesthetic use.	The Zerona® Z6 OTCdevice is indicated foruse as a non-invasivedermatological aesthetictreatment for thereduction ofcircumference of hips,waist, and thighs.	The BioPhotasLifeLight device isintended todeliver heat in theIR spectrum toprovide topicalheating for thepurpose ofelevating tissuetemperature; forthe temporaryrelief of minormuscle and joint	The subject deviceindication for use isessentially identicalto the firstindication for useof the Zerona®predicate device,and essentiallyidentical to the firstindication for useof the IR predicatedevice (LifeLight).
	heating for thepurpose of elevatingtissue temperature;for the temporaryrelief of minor muscleand joint pain,arthritis and musclespasm; relievingstiffness; promotingthe relaxation ofmuscle tissue; and totemporarily increaselocal bloodcirculation.			pain, arthritis andmuscle spasm;relieving stiffness;promoting therelaxation ofmuscle tissue; andto temporarilyincrease localblood circulation.The bluespectrum light isintended toreduce theappearance ofmild to moderateacne vulgaris.
Non-invasive?	Yes	Yes	Yes	Yes	Same
Lamp Specifications
Wavelength	635nm880nm	660nm	635nm	464nm, 640nm,880nm	Similar
OutputIntensity/Irradiance(mW/cm²)	4.1mW/cm²0.5mW/cm²	5-10mW/cm²	<1mW/cm²	10.9 mW/cm² for465nm	Similar
RecommendedTreatment Time(Minutes)	30 minutes	10 – 20 minutes	0-9.9 minutes	30 minutes	Similar

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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.

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.