Sculpsure
Device Facts
| Record ID | K171111 |
|---|---|
| Device Name | Sculpsure |
| Applicant | Cynosure, Inc. |
| Product Code | PKT · General, Plastic Surgery |
| Decision Date | Jun 13, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.5400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Cynosure SculpSure™ is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs 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, flanks, back, and thighs.
Device Story
SculpSure is a diode laser system for non-invasive lipolysis; utilizes 1060 nm infrared laser energy to heat subcutaneous adipose tissue; console-based system with four applicators secured to patient via belt; operated by clinicians in aesthetic settings; laser energy disrupts adipocyte cells; healthcare providers use device to reduce visible fat bulges; patient benefits include non-surgical body contouring; minor software updates from predicate; no changes to biocompatibility or electrical safety.
Clinical Evidence
Prospective, controlled study at 3 centers; 168 subjects (214 treatment areas: back, outer thigh, inner thigh). Primary endpoints: blind evaluation of pre/post photos, ultrasound-measured adipose tissue thickness change, and 6-point Likert patient satisfaction scale at 12 weeks. Results: 86% of post-treatment photos correctly identified; 8.6% mean normalized fat reduction (p<0.01); 83% patient satisfaction rate. Safety analysis showed all adverse events were transient and mild; no serious adverse events reported.
Technological Characteristics
Diode laser system; 1060 ±20 nm wavelength; CW pulse width; max power density 1.4 W/cm²; 4x6 cm² spot size per applicator; belt-based patient attachment; 200-240V power; software-controlled; non-invasive.
Indications for Use
Indicated for non-invasive lipolysis of abdomen, flanks, back, and thighs in individuals with BMI ≤ 30 to reduce visible fat bulges.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 13, 2017
Cynosure, Inc Ms. Amy Tannenbaum Regulatory Affairs Specialist 5 Carlisle Road Westford, Massachusetts 01886
Re: K171111
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 Dated: April 13, 2017 Received: April 14, 2017
Dear Ms. Tannenbaum:
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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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/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.
Sincerely,
Jennifer R. Stevenson -S3
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) K171111
Device Name SculpSure™
Indications for Use (Describe)
The Cynosure SculpSure™ is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs 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, flanks, back, and thighs.
Type of Use (*Select one or both, as applicable*)
| <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> <line stroke="black" stroke-width="2" x1="2" x2="14" y1="2" y2="14"></line> <line stroke="black" stroke-width="2" x1="14" x2="2" y1="2" y2="14"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
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| <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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Section 5
510(k) Summary
## 510(k) Summary for SculpSure Laser System
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<br>Westford, MA 01886 |
| Phone Number | (781)-993-2454 |
| Fax Number | (978) 256-6556 |
| Establishment Registration<br>Number | 1222993 |
| Contact Person | Amy Tannenbaum |
| Preparation Date | April 13, 2017 |
| 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 K160470<br>Zeltiq Coolsculpting K162050<br>The predicate devices have not been subject to a design-related<br>recall. |
| 807.92(a)(4) Device Description | |
| | The Cynosure SculpSure is a diode laser system. The main<br>components of SculpSure are a console and four applicators that<br>deliver the laser energy to the patient. Electrically efficient<br>semiconductors generate optical radiation (1060 nm) which is<br>used to deliver laser energy to subcutaneous tissue layers. |
| 807.92(a)(5) Intended Use of the Device | |
| | The SculpSure laser system is intended for non-invasive lipolysis<br>of the abdomen, flanks, back, and thighs, in individuals with a |
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Section 5
510(k) Summary
| 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 | K160470 | K162050 |
| 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<br>(infrared) | 1060 ±20 nm<br>(infrared) | N/A |
| Spot Size | 4 x 6 cm² on each of<br>the Applicator heads | 4 x 6 cm² on each of<br>the Applicator heads | 4.5 x 7 cm² (2x)<br>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 | 200-240V~, Single Phase | N/A |
| Current | 20A | 20A | N/A |
807.92(b)(1) Non-clinical tests submitted
There have been minor changes to the software from the previously cleared SculpSure in K160470. These changes have been addressed and additional information is available in Section 16. There have been no changes to the biocompatibility or electrical safety testing from the previously cleared SculpSure device. Additional information is available in Section 15 and Section 17, respectively.
807.92(b)(2) Clinical tests submitted
Prospective, controlled studies were conducted at 3 study centers to evaluate the safety and efficacy of Cynosure SculpSure laser for the non-invasive fat reduction of the inner thigh, outer thigh and back. The study was conducted in the same manner as the previous abdomen and flanks studies. The treatment techniques used and subsequent follow up schedule for the study were kept consistent between the studies. A total of 168 subjects, making up 214 treatment areas, were enrolled in the study. This is broken down into 55 subjects/55 treatment areas for back, 52 subjects/52 treatment areas for outer thigh, and 61 subjects/107 treatment areas for inner thighs
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Each subject received 1 treatment with the SculpSure. Treatment effectiveness was assessed through blind evaluation of pre and post treatment (12-week) photographs; percentage change in the adipose tissue thickness from baseline to the12-week follow up measured through ultrasound imaging; and patient satisfaction measured at the 12-week post treatment follow up visit through a 6-point Likert scale. All subjects that were treated in the study were included in the safety analysis and adverse events were assessed at all visits. On an average, blind evaluators were able to identify 86% of the post treatment photographs (back 91%, outer thigh 87% and inner thigh 83%); ultrasound imaging at 12-week post follow up visit showed 8.6% normalized fat reduction (back 10.6%, outer thigh 7.2%, and inner thigh 8.0%). All treatments had a p-value of <0.01 indicating that results were statistically significant. The patient satisfaction survey at 12 week post follow up visit showed 83% satisfaction rate (back 81%, outer thigh 88% and inner thigh 80%). All168 subjects were included in the safety analysis and adverse events reporting. All events were transient and majority was mild in nature. There were no serious adverse events. The study concluded that the SculpSure is safe and effective for non-invasive fat reduction for the back and thighs.
## 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. Additionally, the successful clinical performance of SculpSure as documented in the clinical study demonstrate that the SculpSure has a safety and effectiveness profile that is similar to its predicate devices with a successful treatment of the back and thighs.
