SculpSure

K171992 · Cynosure, Inc. · PKT · Sep 26, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K171992
• Device Name: SculpSure
• Applicant: Cynosure, Inc.
• Product Code: PKT · General, Plastic Surgery
• Decision Date: Sep 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Cynosure SculpSure laser system 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. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a Body Mass Index (BMI) of 43 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs, and submental area.

Device Story

SculpSure is a diode laser system for non-invasive lipolysis; utilizes 1060 nm infrared optical radiation to heat subcutaneous adipose tissue. System comprises a console and four applicators; applicators secured to patient via belts (body) or headgear/straps (submental). Operated by clinicians in a clinical setting. Laser energy disrupts adipocyte cells; heat-assisted mechanism reduces fat bulges. Clinicians monitor treatment; output affects fat appearance. Benefits include non-invasive fat reduction without surgery.

Clinical Evidence

Prospective, controlled study (N=57) evaluated submental fat reduction. Subjects received up to 2 treatments. Endpoints: blind photo evaluation, ultrasound-measured adipose tissue thickness, and patient satisfaction (Likert scale) at 12 weeks. Results: 93% (51/55) of post-treatment photos correctly identified; 15.2% (1.785mm) normalized fat reduction; 100% (55/55) patient satisfaction. Adverse events included swelling, pain, nodules, redness, hardness, numbness, hair loss, itching, bruising, and blisters; events were transient and mostly mild/moderate.

Technological Characteristics

Diode laser system; 1060 ±20 nm wavelength; CW pulse width. Power density: up to 1.4 W/cm2 (body), 2.35 W/cm2 (submental). Materials: patient-contacting materials compliant with ISO 10993-1. Electrical: 200-240V, 20A. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1. Connectivity: N/A.

Indications for Use

Indicated for non-invasive lipolysis of abdomen, flanks, back, and thighs (BMI ≤30) and submental area (BMI ≤43) 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

• Cynosure SculpSure (K171111)
• Zeltiq Coolsculpting (K162050)

Submission Summary (Full Text)

{0}------------------------------------------------

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 26, 2017

Cynosure, Inc. Amy Tannenbaum Regulatory Affairs Specialist 5 Carlisle Road Westford, Massachusetts 01886

Re: K171992

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: June 30, 2017 Received: July 3, 2017

Dear Amy 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-

Image /page/0/Picture/11 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.

{1}------------------------------------------------

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 (DICE) at its toll-free number [phone] or [phone] 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv.

Image /page/1/Picture/9 description: The image shows the name "Jennifer R. Stevenson -S3" in a large, sans-serif font. The text is black and appears to be against a white background. In the background, the letters "FDA" are faintly visible in a light blue color, suggesting the image may be related to the Food and Drug Administration.

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) Kpending

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. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a BMI of 43 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area.

| 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.

This section applies only 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:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 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.

| <b>807.92(a)(1) Submitter Information</b> | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Cynosure, Inc. |
| Address | 5 Carlisle Road<br>Westford, MA 01886 |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Establishment Registration<br>Number | 1222993 |
| Contact Person | Amy Tannenbaum |
| Preparation Date | June 30, 2017 |
| <b>807.92(a)(2) Name of Device</b> | |
| 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 |
| <b>807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed</b> | |
| Predicate Devices | Cynosure SculpSure K171111, Zeltiq Coolsculpting K162050<br>The predicate devices have not been subject to a design-related<br>recall |
| <b>807.92(a)(4) Device Description</b> | |
| 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. | |
| <b>807.92(a)(5) Intended Use of the Device</b> | |
| The SculpSure laser system is intended for non-invasive lipolysis<br>of the abdomen, flanks, back, and thighs in individuals with a<br>Body Mass Index (BMI) of 30 or less. In addition, the device is<br>intended for non-invasive lipolysis of the submental area in<br>individuals with a Body Mass Index (BMI) of 43 or less. The<br>device is intended to affect the appearance of visible fat bulges in | |

{4}------------------------------------------------

| the abdomen, flanks, back, thighs, and submental area. | | | |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------|
| 807.92(a)(6) Summary of the Technological Characteristics of the Device Compared to the<br>Predicate | | | |
| | Proposed SculpSure<br>Laser System | Cynosure SculpSure<br>Laser System | Zeltiq Coolsculpting<br>Device |
| 510(k) Number | KPending | K171111 | 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<br>(up to four applicators<br>per body treatment)<br>14.28 cm2 (one<br>applicator head and<br>frame used for<br>Submental treatment) | 4 x 6 cm2 on each of<br>the Applicator heads<br>(up to four applicators<br>per treatment) | 4.5 x 7 cm2 (2x)<br>approximate |
| Pulse Width (laser<br>ON time) | CW | CW | N/A |
| Power Density | Up to 1.4 W/cm2<br>(body)<br>Up to 2.35 W/cm2<br>(submental) | Up to 1.4 W/cm2 | N/A |
| Attachment to<br>patient | Belt (body treatment)<br>Headgear and straps<br>(submental treatment) | Belt (body treatment<br>only) | Belt |
| Voltage | 200-240V~, Single<br>Phase | 200-240V~, Single<br>Phase | N/A |
| Current | 20A | 20A | N/A |

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. Additional bench testing was performed to demonstrate that the submental mask provides beam uniformity to the treatment area within +/- 15% specification.

{5}------------------------------------------------

## 807.92(b)(2) Clinical tests submitted

A prospective, controlled study was conducted at 3 study centers to evaluate the safety and efficacy of Cynosure SculpSure laser for the non-invasive fat reduction of the submental area. The treatment techniques used and subsequent follow up schedule for the study were kept consistent between the three studies. 57 subjects were enrolled in the study. 23 of the subjects had a BMI of less than 30, and 34 subjects had a BMI of 30 or higher. Each subject received up to 2 treatments with SculpSure at the submental area. There were 5 patients that received 1 treatment, and the rest received 2 treatment effectiveness was assessed through blind evaluation of pre- and post- final treatment (12 week) photographs; percentage change in the adipose tissue thickness from baseline to 12 week follow up measured through ultrasound imaging; and patient satisfaction measured at the 12 week post- final treatment follow up visit through 6 point Likert scale. On an average, blind evaluators were able to identify 93% (51/55) of the post treatment photographs; ultrasound imaging at 12 week post follow up visit showed 15.2% (1.785mm) normalized fat reduction and patient satisfaction survey at 12 week post follow up visit showed 100% (55/55 subjects) satisfaction rate. All subjects that were treated in the study (N=57) were included in the safety analysis and adverse events were assessed at all visits. The side effects that were reported were swelling, pain, nodules, redness, hardness, numbness, hair loss, itching, bruising, and blisters. All events, except for one, were transient and the majority were mild or moderate in nature. There was no significant difference between the safety and efficacy results of the subjects that had a BMI below 30 as compared to the safety and efficacy results of the subjects that had a BMI of 30 or above. The study concluded that the SculpSure is safe and effective for non-invasive fat reduction at the submental area.

### 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 clinical study demonstrate that the SculpSure has a safety and effectiveness profile that is similar to its predicate devices. Therefore, Cynosure is requesting clearance for treatment of the submental area.