K Number

Device Name

Contour Light CL-100

Manufacturer

Contour Research, LLC

Date Cleared

2021-05-19

(231 days)

Product Code

OLI

Regulation Number

878.5400

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K130341, K143007, K122237

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies do not mention any AI or ML components. The device is a simple LED light system controlled by software for selecting and maintaining light application.

Therapeutic

Yes

Explanation: The device is indicated for the temporary relief of minor muscle spasms, pain, and stiffness associated with arthritis, promoting relaxation of muscle tissue, and temporarily increasing local blood circulation, which are all therapeutic benefits.

Diagnostic

The device description and intended use indicate it is used for aesthetic treatment and temporary relief of minor muscle pain and stiffness, which are therapeutic, not diagnostic, purposes.

SaMD (Software as a Medical Device)

The device description explicitly states it is comprised of a panel of LEDs, a software-controlled console, a power adaptor, and cables, indicating it is a hardware device with software control, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Contour Light CL-100 device is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended uses are for non-invasive dermatological aesthetic treatment (circumference reduction) and topical heating for temporary relief of pain and stiffness, promoting relaxation, and increasing local blood circulation. These are all treatments applied to the body, not tests performed on samples taken from the body.
Device Description: The device is a low-level laser/LED system that applies light externally to the skin. It does not involve the analysis of biological samples.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.

In summary, the Contour Light CL-100 is a therapeutic device that applies energy to the body for aesthetic and pain relief purposes, not a diagnostic device that analyzes samples to provide information about a patient's health status.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

OLI, ILY

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hips, waist, and thighs

Indicated Patient Age Range

Adults

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Clinical Performance Data: None submitted.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K130341, K143007, K122237

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

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

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.

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:

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"An agency many not conduct or sponsor, and a person is not required to respond to, a collection of information

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FORM FDA 3881 (7/17)

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
Infrared Lamp
Regulation Number:	21 CFR §878.5400
21 CFR §890.5500
Product Codes:	OLI, ILY
Class:	II

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.

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
Cream Low Level
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-
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 device is intended
to deliver heat in the
IR spectrum to
provide topical	The low level laser
model Strawberry
and Strawberry and
Cream can be used
for the non-invasive
temporary reduction
in waist
circumference by the
disruption of
adipocyte cells
within the fat layer
for the release of fat
and lipids from these
cells for non-invasive
aesthetic use.	The Zerona® Z6 OTC
device is indicated for
use as a non-invasive
dermatological aesthetic
treatment for the
reduction of
circumference of hips,
waist, and thighs.	The BioPhotas
LifeLight device 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	The subject device
indication for use is
essentially identical
to the first
indication for use
of the Zerona®
predicate device,
and essentially
identical to the first
indication for use
of the IR predicate
device (LifeLight).
	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.			pain, arthritis and
muscle spasm;
relieving stiffness;
promoting the
relaxation of
muscle tissue; and
to temporarily
increase local
blood circulation.
The blue
spectrum light is
intended to
reduce the
appearance of
mild to moderate
acne vulgaris.
Non-invasive?	Yes	Yes	Yes	Yes	Same
Lamp Specifications
Wavelength	635nm
880nm	660nm	635nm	464nm, 640nm,
880nm	Similar
Output
Intensity/Irradiance
(mW/cm²)	4.1mW/cm²
0.5mW/cm²	5-10mW/cm²