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 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.

AI/ML Overview

This document is a 510(k) summary for the Cynosure SculpSure device, which is a diode laser system intended for non-invasive lipolysis. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria through a dedicated study with performance metrics. Therefore, many of the requested details about acceptance criteria, detailed study design, and performance metrics are not explicitly available in this document.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with numerical performance data for specific clinical outcomes. The clinical performance is described in terms of "affecting the appearance of visible fat bulges."

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Non-invasive lipolysis of abdomen and flanks	Intended to affect the appearance of visible fat bulges in the abdomen and flanks.
Safety within specified operating parameters	Non-clinical tests (electrical safety, EMC, biocompatibility) confirm safety standards are met.
Functionality as intended	Software verification and validation confirm software performs as intended. Power output meets specification.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: "Not applicable, no change in indication for use." This implies that the current 510(k) submission did not include a new clinical test set to prove device efficacy for the stated indications. Instead, it relies on the previous approvals of its predicate devices.
Data Provenance: Not applicable for a new clinical test set in this submission. The original predicate devices' approvals would have contained this information. It is not mentioned whether any retrospective or prospective data was used for this specific submission beyond the predicate device references.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable as no new clinical test set was submitted for this 510(k) for evaluating efficacy.

4. Adjudication Method for the Test Set:

Not applicable as no new clinical test set was submitted for this 510(k).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC comparative effectiveness study is mentioned in this 510(k) summary. The submission focuses on substantial equivalence based on technological characteristics and safety, not on comparative effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The SculpSure device is a physical laser system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context. The device's performance is inherently linked to its physical output and application by a user.

7. The Type of Ground Truth Used:

For the intended use of "affecting the appearance of visible fat bulges," the ground truth in previous studies for the predicate devices (or the original SculpSure K150230) would likely have involved clinical assessment of fat reduction (e.g., circumferences, caliper measurements, imaging such as ultrasound or MRI, and potentially patient/physician satisfaction surveys). However, this specific 510(k) does not detail new efficacy studies.
For non-clinical tests:
- Software verification and validation: Ground truth is the predefined functional requirements and specifications of the software.
- Power output testing: Ground truth is the specified power output range.
- Biocompatibility: Ground truth is ISO 10993-1 standards.
- Electrical safety and EMC: Ground truth is the specified international standards (e.g., IEC 60601-1).

8. The Sample Size for the Training Set:

Not applicable as this 510(k) is not for an AI/algorithm-based device that requires a training set in the typical machine learning sense. The device is a physical laser system.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the same reason as point 8.

Summary of the Study that Proves Device Meets Acceptance Criteria (based on the provided document):

The provided document (K160470) is an administrative change to a previous 510(k) and refers back to the original substantial equivalence determination for SculpSure (K150724 and K150230). This specific submission does not contain new clinical studies to prove efficacy. Instead, it relies on demonstrating substantial equivalence to its own previously cleared versions and other predicate devices, citing "no change in indication for use."

The "studies" that support the device meeting acceptance criteria (in terms of safety and performance for its intended use) are:

Non-clinical tests:
- Software verification and validation.
- Power output testing.
- Electromagnetic compatibility (EMC) and electrical safety testing (per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
- Biocompatibility assessment (per ISO 10993-1).

These non-clinical tests aimed to ensure the device's technical specifications, safety, and compatibility were met, demonstrating that the device "should perform as intended in the specified use conditions." The efficacy for "non-invasive lipolysis of the abdomen and flanks" was established in the earlier 510(k) submissions for the predicate SculpSure devices.

Summary

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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 (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)

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

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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 RoadWestford, MA 01886
Phone Number	(978) 367-8736
Fax Number	(978) 256-6556
Establishment RegistrationNumber	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, K150230Zeltiq Coolsculpting K151179The predicate devices have not been subject to a design-relatedrecall
807.92(a)(4) Device Description
	The Cynosure SculpSure is a diode laser system. The maincomponents of SculpSure are a console and four applicators thatdeliver the laser energy to the patient. Electrically efficientsemiconductors generate optical radiation (1060 nm) which isused 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 aBody 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 andflanks.
807.92(a)(6) Summary of the Technological Characteristics of the Device Compared to thePredicate
	Proposed SculpSureLaser System	Cynosure SculpSureLaser System	Zeltiq CoolsculptingDevice
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 ofthe Applicator heads	4 x 6 cm² on each ofthe Applicator heads	4.5 x 7 cm² (2x)approximate
Pulse Width (laserON time)	CW	CW	N/A
Power Density	Up to 1.4 W/cm²	Up to 1.4 W/cm²	N/A
Attachment topatient	Belt	Belt	Belt
Voltage	200-240V~, SinglePhase	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.

Regulation Number and Section

§ 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.