(90 days)
Not Found
No
The description mentions an embedded microcontroller for automatic calculation of energy output, which is a standard control system function and does not indicate AI/ML. There are no mentions of AI, ML, or related terms, nor any description of training or test data sets typically associated with AI/ML development.
Yes
The device is indicated for "non-invasive aesthetic treatment for the temporary reduction in circumference of the waist," which is a therapeutic purpose.
No
The "Intended Use / Indications for Use" section states the device is for "non-invasive aesthetic treatment for the temporary reduction in circumference of the waist," not for diagnosing conditions.
No
The device description explicitly states it consists of a main console and treatment paddles containing laser diodes, indicating it is a hardware-based device with embedded software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "non-invasive aesthetic treatment for the temporary reduction in circumference of the waist." This is a therapeutic/aesthetic application, not a diagnostic one.
- Device Description: The device uses laser energy applied externally to the body. IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health or condition.
- Clinical Study: The clinical study measures the reduction in waist circumference, which is a physical measurement, not a diagnostic test result from a biological sample.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples for diagnostic purposes. The CURVE Laser System operates in vivo (on the body) for aesthetic treatment.
N/A
Intended Use / Indications for Use
The CURVE Laser System is indicated for non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.
Product codes
OLI
Device Description
The CURVE Laser System consists of a main console and 4 treatment paddles. The console houses the main electronics, controls and embedded software. The liquid crystal display (LCD) identifies all key treatment parameters. The main console is also equipped with a micro controller that provides automatic calculation of energy output for a specific set of treatment parameters. The treatment paddles are constructed so that each paddle contains 8 laser emission diode sources at a power output of 40mW per laser diode. These treatment paddles are non-thermal and non-invasive, at a wavelength of 630-680.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Waist
Indicated Patient Age Range
Not Found
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
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Summary of Performance Studies
Clinical Testing: At the request of CDRH, a randomized, double blind clinical study was conducted in which 19 subjects were treated with the CURVE Laser System and 18 subjects received the control (sham) device. The CURVE successfully met the primary efficacy endpoint of this study, which was the achievement of at least 1 inch loss from baseline in averaged waistline measurement at the final visit, with 100% of subjects receiving treatment with the CURVE device losing at least 1 inch in their waistline compared with 0 subjects in the arm receiving treatment with the sham device. In addition, no device-related AEs or deaths were reported for any subject during the course of this study. Taken together, these data demonstrate that the CURVE device safely and successfully reduces waistline circumference after a course of nine 20-minute treatments in a 3-week period.
Key Metrics
Successfully met the primary efficacy endpoint of at least 1 inch loss from baseline in averaged waistline measurement at the final visit. 100% of subjects receiving treatment with the CURVE device losing at least 1 inch in their waistline compared with 0 subjects in the arm receiving treatment with the sham device. No device-related AEs or deaths were reported.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal is a symbol that appears to be three stylized profiles of human faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002
June 6, 2017
YOLO Medical, Inc. % Paul Kramsky President Rockin' Regulatory. Inc. 21831 Tumbleweed Circle Lake Forest. California 92630
Re: K170709
Trade/Device Name: CURVE Laser System Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System for Aesthetic Use Regulatory Class: Class II Product Code: OLI Dated: March 6, 2017 Received: March 8, 2017
Dear Mr. Kramsky:
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. The general controls provisions of the Actinclude 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
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For Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) TBD K170709
Device Name CURVE Laser System
Indications for Use (Describe)
The CURVE Laser System is indicated for non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.
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) |
|---|---|
| ☑ | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary for the CURVE Laser System
Submission Sponsor: 1.
Yolo Medical Inc. #245 - 1959 152nd Street Surrey, British Columbia V4A 9E3 CANADA Telephone: 604-542-2200 Fax: 604-542-2205 FDA Establishment Registration #: 3008970597
2. Submission Correspondent:
Rockin' Regulatory, Inc. 21831 Tumbleweed Circle Lake Forest, CA 92630 Telephone: 949-636-1464 Contact: Paul Kramsky, President Email: pkramsky@cox.net
3. Date Prepared:
May 31, 2017
4. Device Name:
| Trade/Proprietary Name: | CURVE Laser System |
|---|---|
| Common Name: | Low Level laser System (revised) |
| Classification Name: | Low Level Laser System for Aesthetic Use |
| Product Code: | OLI |
| Regulation Number: | 878.5400 |
| Device Class | II Special Controls |
5. Substantial Equivalence:
The CURVE Laser System is substantially equivalent in terms of both intended
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use and technological characteristics to the Yolo Medical's Lipofina Laser System, which was cleared for marketing under K143741 on April 24, 2015 for non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.
Device Description: 6.
The CURVE Laser System consists of a main console and 4 treatment paddles. The console houses the main electronics, controls and embedded software. The liquid crystal display (LCD) identifies all key treatment parameters. The main console is also equipped with a micro controller that provides automatic calculation of energy output for a specific set of treatment parameters. The treatment paddles are constructed so that each paddle contains 8 laser emission diode sources at a power output of 40mW per laser diode. These treatment paddles are non-thermal and non-invasive, at a wavelength of 630-680.
7. Indications for Use:
The CURVE Laser System is indicated for non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.
8. Performance Data:
The CURVE Laser System was tested and demonstrated to be in compliance with IEC 60601-2-22, Medical Electrical Equipment, Particular Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment, IEC 60601-1 -- Medical electrical equipment Part 1: General requirements for basic safety and essential performance, and IEC 60601-1-2 -- Electromagnetic Compatibility (EMC) – Part 1: General Requirements for Safety; Electromagnetic compatibility.
Clinical Testing: 9.
At the request of CDRH, a randomized, double blind clinical study was conducted in which 19 subjects were treated with the CURVE Laser System and 18 subjects received the control (sham) device. The CURVE successfully met the primary efficacy endpoint of this study, which was the achievement of at least 1 inch loss from baseline in averaged waistline measurement at the final
5
visit, with 100% of subjects receiving treatment with the CURVE device losing at least 1 inch in their waistline compared with 0 subjects in the arm receiving treatment with the sham device. In addition, no device-related AEs or deaths were reported for any subject during the course of this study. Taken together, these data demonstrate that the CURVE device safely and successfully reduces waistline circumference after a course of nine 20-minute treatments in a 3-week period.
Conclusions 10.
Based on the technical comparison between the CURVE Laser System and the predicate Lipofina Laser System and the clinical data provided in this application, it can be concluded that the CURVE Laser System is Substantially Equivalent to the Lipofina Laser System.