SculpSure

K160470 · Cynosure, Inc. · PKT · Jul 21, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K160470
• Device Name: SculpSure
• Applicant: Cynosure, Inc.
• Product Code: PKT · General, Plastic Surgery
• Decision Date: Jul 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Diode laser system for non-invasive lipolysis; utilizes 1060 nm infrared optical radiation to heat subcutaneous tissue layers; console-based unit with four applicators secured to patient via belt; physician-operated in clinical setting; heat-assisted mechanism disrupts adipocyte cells to reduce visible fat bulges; output provides aesthetic body contouring benefits; device performance verified through power output testing and software validation.

Clinical Evidence

No clinical data submitted; substantial equivalence supported by non-clinical bench testing, including software verification/validation, electrical safety, electromagnetic compatibility, and biocompatibility assessments.

Technological Characteristics

Diode laser system; 1060 ±20 nm wavelength; continuous wave (CW) pulse width; power density up to 1.4 W/cm²; 4x6 cm² spot size per applicator; 200-240V power; belt-based patient attachment. Biocompatibility per ISO 10993-1. Electrical safety/EMC per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.

Indications for Use

Indicated for non-invasive lipolysis of abdomen and flanks in individuals with BMI ≤ 30 to affect appearance of 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 (K150724)
• CynoSure SculpSure (K150230)
• Zeltiq Coolsculpting (K151179)

Submission Summary (Full Text)

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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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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

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(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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# Section 5 – 510(k) Summary

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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<br>Westford, MA 01886 |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Establishment Registration<br>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<br>Zeltiq Coolsculpting K151179<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 Cynosure SculpSure is a diode laser system intended for non-<br>invasive lipolysis of the abdomen and flanks in individuals with a<br>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<br>flanks. | | | |
|------------------------------------------------------------------------------------------------------|----------------------------------------------|----------------------------------------------|---------------------------------|
| 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 | 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<br>(infrared) | 1064 ± 25nm<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<br>ON time) | CW | CW | N/A |
| Power Density | Up to 1.4 W/cm² | Up to 1.4 W/cm² | N/A |
| Attachment to<br>patient | Belt | Belt | Belt |
| Voltage | 200-240V~, Single<br>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.