(153 days)
Not Found
No
The summary describes a laser system for lipolysis and does not mention any AI or ML components or functionalities.
Yes
The device is intended for non-invasive lipolysis to affect the appearance of visible fat bulges, which is a therapeutic intervention aimed at changing a body function or structure.
No
Explanation: The device is intended for non-invasive lipolysis to affect the appearance of visible fat bulges, which is a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is a "diode laser system" with "a console and four applicators that deliver the laser energy to the patient," indicating it is a hardware-based medical device.
Based on the provided information, the Cynosure SculpSure device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for non-invasive lipolysis (fat reduction) of the abdomen and flanks using a laser system. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a laser system that delivers energy to subcutaneous tissue. This is a physical intervention, not a test performed on biological samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to physically alter tissue.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SculpSure device does not fit this description.
N/A
Intended Use / Indications for Use
Cynosure SculpSure is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen and flanks.
Product codes
PKT, OOK
Device Description
The Cynosure SculpSure is a diode laser system. The main components of SculpSure are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which is used to deliver laser energy to subcutaneous tissue layers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen and flanks
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
Not Found
Summary of Performance Studies
Non-clinical tests submitted: Software verification and validation was performed. and it was demonstrated that the software performs as intended. Testing confirmed that the power output meets specification. Electromagnetic compatibility and electrical safety testing was performed per standards IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22 and IEC 60825-1. Results confirmed the device meets the standards. All patient contacting materials were assessed as per ISO 10993-1 and found to be biocompatible.
Clinical tests submitted: Not applicable, no change in indication for use.
Conclusions drawn from clinical and non-clinical tests submitted: Cynosure believes that SculpSure is substantially equivalent to its predicate devices with same intended use and similar technological characteristics. The non-clinical data for SculpSure supports the safety of the device and the biocompatibility, hardware and software verification and validation demonstrate that the SculpSure should perform as intended in the specified use conditions.
Key Metrics
Not Found
Predicate Device(s)
CynoSure SculpSure K150724, K150230, Zeltiq Coolsculpting K151179
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/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue text.
CynoSure, Inc. Aastha Kohli Senior Regulatory Affairs Specialist 5 Carlisle Road Westford, Massachusetts 01886
August 11, 2022
Re: K160470
Trade/Device Name: SculpSure Regulation Number: 21 CFR 878.5400 Regulation Name: Low level laser system for aesthetic use Regulatory Class: Class II Product Code: PKT
Dear Aastha Kohli:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 21, 2016. Specifically, FDA is updating this SE Letter to remove OOK as an administrative correction, because OOK (Dermal Cooling Pack/Vacuum/Massager) does not apply to your device.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Long Chen, Ph.D., OHT4: Office of Surgical and Infection Control Devices, 301-796-6389, Long.Chen(@fda.hhs.gov.
Sincerely,
Long H. Chen -S Digitally signed by Long H. Chen -S
Date: 2022.08.11 13:59:36 -04'00'
Long Chen, Ph.D. Director (Acting) 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
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2016
CynoSure, Inc. Ms. Aastha Kohli Senior Regulatory Affairs Specialist 5 Carlisle Road Westford, MA 01886
Re: K160470
Trade/Device Name: SculpSure Regulation Number: 21 CFR 878.5400 Regulation Name: Low level laser system for aesthetic use Regulatory Class: Class II Product Code: PKT, OOK Dated: June 14, 2016 Received: June 15, 2016
Dear Ms. Kohli:
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 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 and 809); medical device reporting
2
(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
Sincerely yours,
Christopher J. Ronk -S
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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Indications for Use
510(k) Number (if known) K160470
Device Name Sculpsure
Indications for Use (Describe)
Cynosure SculpSure is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen and flanks.
| 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) |
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Section 5 – 510(k) Summary
5
Section 5
510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| 807.92(a)(1) Submitter Information | |
|---|---|
| Applicant | Cynosure, Inc. |
| Address | 5 Carlisle Road |
| Westford, MA 01886 | |
| Phone Number | (978) 367-8736 |
| Fax Number | (978) 256-6556 |
| Establishment Registration | |
| Number | 1222993 |
| Contact Person | Kevin O'Connell |
| Preparation Date | July 18, 2016 |
| 807.92(a)(2) Name of Device | |
| Trade or Proprietary Name | SculpSure |
| Common or Usual Name | Laser |
| Classification Name | Laser for disruption of adipocyte cells for aesthetic use |
| Classification Panel | General & Plastic Surgery |
| Regulation | 21 CFR 878.5400 |
| Regulatory Class | II |
| Product Code(s) | PKT |
| 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed | |
| Predicate Devices | CynoSure SculpSure K150724, K150230 |
| Zeltiq Coolsculpting K151179 | |
| The predicate devices have not been subject to a design-related | |
| recall | |
| 807.92(a)(4) Device Description | |
| The Cynosure SculpSure is a diode laser system. The main | |
| components of SculpSure are a console and four applicators that | |
| deliver the laser energy to the patient. Electrically efficient | |
| semiconductors generate optical radiation (1060 nm) which is | |
| used to deliver laser energy to subcutaneous tissue layers. | |
| 807.92(a)(5) Intended Use of the Device | |
| The Cynosure SculpSure is a diode laser system intended for non- | |
| invasive lipolysis of the abdomen and flanks in individuals with a | |
| Body Mass Index (BMI) of 30 or less. The device is intended to |
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Section 5
510(k) Summary
| affect the appearance of visible fat bulges in the abdomen and
| flanks. | |||
|---|---|---|---|
| 807.92(a)(6) Summary of the Technological Characteristics of the Device Compared to the | |||
| Predicate | |||
| Proposed SculpSure | |||
| Laser System | Cynosure SculpSure | ||
| Laser System | Zeltiq Coolsculpting | ||
| Device | |||
| 510(k) Number | Pending | K150230, K150230 | K151179 |
| Manufacturer | Cynosure, Inc. | Cynosure, Inc. | Zeltiq Aesthetics, Inc. |
| Lipolysis Method | Heat-assisted | Heat-assisted | Cold-assisted |
| Device Type | Diode Laser | Diode Laser | N/A |
| Wavelength | 1060 ±20 nm | ||
| (infrared) | 1064 ± 25nm | ||
| (infrared) | N/A | ||
| Spot Size | 4 x 6 cm² on each of | ||
| the Applicator heads | 4 x 6 cm² on each of | ||
| the Applicator heads | 4.5 x 7 cm² (2x) | ||
| approximate | |||
| Pulse Width (laser | |||
| ON time) | CW | CW | N/A |
| Power Density | Up to 1.4 W/cm² | Up to 1.4 W/cm² | N/A |
| Attachment to | |||
| patient | Belt | Belt | Belt |
| Voltage | 200-240V~, Single | ||
| Phase | 120V | N/A | |
| Current | 20A | 20A | N/A |
807.92(b)(1) Non-clinical tests submitted
Software verification and validation was performed. and it was demonstrated that the software performs as intended. Testing confirmed that the power output meets specification.
Electromagnetic compatibility and electrical safety testing was performed per standards IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22 and IEC 60825-1. Results confirmed the device meets the standards. All patient contacting materials were assessed as per ISO 10993-1 and found to be biocompatible.
807.92(b)(2) Clinical tests submitted
Not applicable, no change in indication for use.
807.92(b)(3) Conclusions drawn from clinical and non-clinical tests submitted
Cynosure believes that SculpSure is substantially equivalent to its predicate devices with same intended use and similar technological characteristics. The non-clinical data for SculpSure supports the safety of the device and the biocompatibility, hardware and software verification and validation demonstrate that the SculpSure should perform as intended in the specified use conditions.