(103 days)
Not Found
No
The summary describes a laser system for lipolysis and does not mention any AI or ML components or functionalities.
No.
The device is intended for non-invasive aesthetic use (lipolysis for fat reduction), not for treating a disease or medical condition.
No.
The device description and intended use clearly state that the Cynosure SculpSure is for non-invasive lipolysis and aesthetic use, which is a treatment, not a diagnosis.
No
The device description explicitly states that the Cynosure SculpSure is a "diode laser system" with "main components of a console and applicator," indicating it is a hardware-based medical device.
Based on the provided information, the Cynosure SculpSure is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SculpSure's Function: The SculpSure device directly applies laser energy to the skin's surface to disrupt fat cells within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use." This describes a treatment or aesthetic procedure, not a diagnostic test.
- Device Description: The description details a laser system that irradiates the skin, consistent with a therapeutic or aesthetic device, not an IVD.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, diagnostic markers, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Cynosure SculpSure is a therapeutic or aesthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cynosure SculpSure is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less.
The Cynosure SculpSure is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less
Product codes
PKT
Device Description
The Cynosure SculpSure is a diode laser system. Electrically efficient semiconductors generate optical radiation (1064 nm) which is used to directly irradiate the skin's surface. The Sculpsure is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. The main components of SculpSure are a console and applicator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen
Indicated Patient Age Range
The clinical study was performed at two centers using 35 subjects ages 23 - 61
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
A preliminary study was performed to demonstrate the use of hyperthermic treatment to cause the same type of injury to adipocytes as hypothermic treatment (predicate). It was concluded that histologic, quantitative measurements, as well as aesthetic level of improvement show comparable results between hyperthermic and hypothermic treatment of adipocytes resulting in fat reduction.
Pre-clinical testing was performed to demonstrate that the device would elevate the temperature of the tissue to 42 - 47 °C.
The clinical study was performed at two centers using 35 subjects ages 23 - 61 with unwanted fat in the abdomen. Racial demographics of the subjects included: Caucasian, African American, and Hispanic. The BMI of the subjects ranged from 20.9 to 31.6. 33 of the subjects were female and 2 were male.
The primary endpoint was photographic evaluations with correct identification of pre-treatment images compared to post treatment images. Secondary endpoint was a change from baseline in adipose layer thickness between device and control based on ultrasound measurements. The third endpoint was subject satisfaction survey.
Before treatment each subject was photographed, ultrasound images taken and weight recorded. Each subject received one treatment with the device. Post treatment follow up was at 1 week (optional), 6 weeks and 12 weeks.
Before and after (12 week post treatment) photographs of the 34 of 35 subjects that returned were evaluated individually by three blinded evaluators. In 95% of the total individual evaluations the evaluators correctly identified the before and after images. The blinded evaluators were board certified dermatologists. There was an average of 11.5% fat reduction based on ultrasound measurements at 12 weeks. Ninety one percent of the patients rated the treatment satisfied on the Likert Satisfaction scale. Therefore all endpoints were met.
Patients were evaluated for adverse events immediately after treatment and at all follow up visits. There were no deaths, serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) reported in this study. The events that were logged were typical reactions to laser treatments including edema, bruising, pain, and erythema; nodule and hardness due to inflammation. All events transient and resolved without medical intervention.
Nonclinical testing performed confirmed that the device met its specifications. Based on the clinical testing performed it was confirmed that SculpSure achieved disruption of adipocyte cells which achieved a desired affect without any serious adverse events or unanticipated adverse device effects.
Key Metrics
95% of the total individual evaluations the evaluators correctly identified the before and after images.
There was an average of 11.5% fat reduction based on ultrasound measurements at 12 weeks.
Ninety one percent of the patients rated the treatment satisfied on the Likert Satisfaction scale.
Predicate Device(s)
Zeltiq Coolsculpting Device K133212, Cynosure Smartlipo MPX Laser K083795, Cynosure 1064 nm Diode Laser K123971
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines connecting them. The text is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 1, 2015
Cynosure, Inc. Kevin O'connell Director Regulatory Affairs 5 Carlisle Road Westford, Massachusetts 01886
Re: K150724
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: March 19, 2015 Received: March 23, 2015
Dear Kevin O'connell:
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K150724
Device Name Cynosure SculpSure
Indications for Use (Describe)
The Cynosure SculpSure is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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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 | |
|---|---|
| Name | Cynosure, Inc. |
| Address | 5 Carlisle Road |
| Westford, MA 01886 | |
| USA | |
| Phone number | 978-367-8736 |
| Fax number | 978-256-6556 |
| Establishment Registration Number | 1222993 |
| Name of contact person | Kevin J. O'Connell |
| Date prepared | June 30, 2015 |
| 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 and Plastic Surgery |
| Regulation | 21 CFR 878.5400 |
| Product Code(s) | PKT |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed | |
| Zeltiq Coolsculpting Device K133212 | |
| Cynosure Smartlipo MPX Laser K083795 | |
| Cynosure 1064 nm Diode Laser K123971 | |
| 807.92(a)(4) - Device description | |
| The Cynosure SculpSure is a diode laser system. Electrically efficient | |
| semiconductors generate optical radiation (1064 nm) which is used to | |
| directly irradiate the skin's surface. The Sculpsure is intended for non- | |
| invasive lipolysis of the abdomen to achieve disruption of adipocyte | |
| cells intended for non-invasive aesthetic use to achieve a desired | |
| aesthetic affect. The main components of SculpSure are a console and | |
| applicator. | |
| 807.92(a)(5) Intended use of the device | |
| Indications for use | The Cynosure SculpSure is intended for non-invasive lipolysis of the |
| abdomen to achieve disruption of adipocyte cells intended for non- | |
| invasive aesthetic use to achieve a desired aesthetic affect. Intended for | |
| individuals with a Body Mass Index (BMI) of 30 or less |
4
| 807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate | ||||
|---|---|---|---|---|
| Characteristic | SculpSure | Zeltiq Coolsculpting | ||
| Device K133212 | Cynosure Smartlipo MPX | |||
| Laser K083795 | Cynosure 1064 nm Diode | |||
| Laser K123971 | ||||
| Lipolysis Method | heat - assisted | cold - assisted | heat - assisted | n/a |
| Laser Type | Diode | N/A | Nd:YAG | Diode |
| Wavelength | 1064 nm | n/a | 1064 nm | 1064 nm |
| Power Density | 1.7 W/cm² | n/a | n/a | 5 W/ cm² |
| Power Modes | Continuous with duty | |||
| cycle | Continuous, Pulse | |||
| Modulation | ||||
| Pulse Length | 1s to 20 s | n/a | 0.1 - 300 ms | 100ms - 500ms |
| Applicator size | 4 x 6 cm² (3X) | 4.5 x 7 cm² (2x) | ||
| approximate | 300,600,1000 μm | 3 x 10 cm² | ||
| Attachment to | ||||
| patient | belt | belt | n/a - fiber is manipulated | |
| by operator | belt | |||
| 807.92(b)(1) NONCLINICAL TESTS SUBMITTED | ||||
| Discussion of nonclinical | ||||
| tests: | Software verification and validation was performed, and demonstrated that the software performs as | |||
| intended. Testing confirmed that the power output met specification. | ||||
| Electromagnetic compatibility and electrical safety testing was performed per standards IEC 60601-1, IEC | ||||
| 60601-1-2, IEC 60825-1 and IEC. Results confirmed the device met the standards. | ||||
| 807.92(b)(2) CLINICAL TESTS SUBMITTED | ||||
| Discussion of Clinical | ||||
| Study: | A preliminary study was performed to demonstrate the use of hyperthermic treatment to cause the same | |||
| type of injury to adipocytes as hypothermic treatment (predicate). It was concluded that histologic, | ||||
| quantitative measurements, as well as aesthetic level of improvement show comparable results between | ||||
| hyperthermic and hypothermic treatment of adipocytes resulting in fat reduction. |
Pre-clinical testing was performed to demonstrate that the device would elevate the temperature of the
tissue to 42 - 47 °C.
The clinical study was performed at two centers using 35 subjects ages 23 - 61 with unwanted fat in the
abdomen. Racial demographics of the subjects included: Caucasian, African American, and Hispanic. The | | | |
5
| BMI of the subjects ranged from 20.9 to 31.6. 33 of the subjects were female and 2 were male. |
|---|
| The primary endpoint was photographic evaluations with correct identification of pre-treatment images |
| compared to post treatment images. Secondary endpoint was a change from baseline in adipose layer |
| thickness between device and control based on ultrasound measurements. The third endpoint was subject |
| satisfaction survey. |
| Before treatment each subject was photographed, ultrasound images taken and weight recorded. Each |
| subject received one treatment with the device. Post treatment follow up was at 1 week (optional), 6 |
| weeks and 12 weeks. |
| Before and after (12 week post treatment) photographs of the 34 of 35 subjects that returned were |
| evaluated individually by three blinded evaluators. In 95% of the total individual evaluations the |
| evaluators correctly identified the before and after images. The blinded evaluators were board certified |
| dermatologists. There was an average of 11.5% fat reduction based on ultrasound measurements at 12 |
| weeks. Ninety one percent of the patients rated the treatment satisfied on the Likert Satisfaction scale. |
| Therefore all endpoints were met. |
| Patients were evaluated for adverse events immediately after treatment and at all follow up visits. There |
| were no deaths, serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) reported in |
| this study. The events that were logged were typical reactions to laser treatments including edema, |
| bruising, pain, and erythema; nodule and hardness due to inflammation. All events transient and resolved |
| without medical intervention. |
Nonclinical testing performed confirmed that the device met its specifications. Based on the clinical testing performed it was confirmed that SculpSure achieved disruption of adipocyte cells which achieved a desired affect without any serious adverse events or unanticipated adverse device effects