(102 days)
Not Found
No
The document describes a laser system for lipolysis and does not mention AI or ML in its description, intended use, or performance studies. The performance evaluation relies on blinded human evaluators and ultrasound measurements.
No
The device is intended for non-invasive lipolysis for aesthetic purposes, not for treating a disease or condition.
No
The device is described as being for "non-invasive lipolysis" and "aesthetic use to achieve a desired affect," with the performance studies focusing on fat reduction and patient satisfaction. There is no mention of diagnosing any disease or condition.
No
The device description explicitly states it is a "diode laser system" with "a console and applicator," indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Cynosure SculpSure Function: The description clearly states that the Cynosure SculpSure is a diode laser system used for non-invasive lipolysis of the flanks. It directly irradiates the skin's surface to disrupt adipocyte cells for aesthetic purposes.
- Lack of Specimen Analysis: The device does not involve the collection or analysis of any biological specimens from the patient. It works externally on the body.
The information provided about the device's intended use, description, performance studies, and anatomical site all point to it being a therapeutic or aesthetic device, not an IVD.
N/A
Intended Use / Indications for Use
Indications for use: The Cynosure is intended for non-invasive lipolysis of the flanks 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.
Product codes (comma separated list FDA assigned to the subject device)
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 flanks 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
flanks
Indicated Patient Age Range
ages 25 - 61
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 49 subjects ages 25 - 61 with unwanted fat in the flanks. Racial demographics of the subjects included: Caucasian, African American, Hispanic, Indian and Asian. The BMI of the subjects ranged from 21.6 to 35. Subjects include all Fitzpatrick skin types (I - VI). 42 of the subjects were female and 7 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 43 of 49 subjects that returned were evaluated individually by three blinded evaluators. In 88% 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 13% normalized fat reduction based on ultrasound measurements at 12 weeks. Ninety eight 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, blistering, and erythema; nodule and hardness due to inflammation. All events transient and resolved without medical intervention.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- 88% of the total individual evaluations the evaluators correctly identified the before and after images.
- average of 13% normalized fat reduction based on ultrasound measurements at 12 weeks.
- Ninety eight percent of the patients rated the treatment satisfied on the Likert Satisfaction scale.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Zeltiq Coolsculpting Device K133212, Cynosure Smartlipo MPX Laser K083795, Cynosure 1064 nm Diode Laser K123971
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2015
Cynosure, Inc. % Kevin O' Connell Director Regulatory Affairs 5 Carlisle Road Westford, Massachusetts 01886
Re: K150230 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: January 30, 2015 Received: February 4, 2015
Dear Mr. 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 yours,
Jennifer R. Stevenson -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) K150230
Device Name Cynosure SculpSure
Indications for Use (Describe)
Indications for use: The Cynosure is intended for non-invasive lipolysis of the flanks 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) | |
|---|---|
| ☑ 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 | May 14, 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 flanks 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 flanks 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. | ||||
| 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 49 subjects ages 25 - 61 with unwanted fat in the | ||||
| flanks. Racial demographics of the subjects included: Caucasian, African American, Hispanic, Indian and | ||||
| Asian. The BMI of the subjects ranged from 21.6 to 35. Subjects include all Fitzpatrick skin types (I - | ||||
| VI). 42 of the subjects were female and 7 were male. |
5
| | 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 43 of 49 subjects that returned were evaluated
individually by three blinded evaluators. In 88% 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 13% normalized fat reduction based on ultrasound measurements at 12 weeks. Ninety
eight 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, blistering, and erythema; nodule and hardness due to inflammation. All events
transient and resolved without medical intervention. |
| 807.92(b)(3) Conclusion | |
Nonclinical testing performed confirmed that the device met its specifications. Clinical testing performed that the device achieved disruption of adipocyte cells which achieved a desired affect without any serious adverse events or unanticipated adverse device effects