(97 days)
Not Found
No
The document describes a laser system for lipolysis and skin tightening. While it mentions image analysis for evaluating treatment effectiveness, there is no indication that AI/ML is used in the device's operation, control, or analysis process. The image analysis protocol is referenced to a published method, not described as an AI/ML algorithm.
Yes.
Explanation: The device is intended for non-invasive lipolysis to reduce fat and improve the appearance of lax tissue, which are considered therapeutic effects.
No
The device is intended for non-invasive lipolysis and improving the appearance of lax tissue, which are therapeutic/cosmetic procedures, not diagnostic functions. While it uses imaging for assessment, it does not diagnose medical conditions.
No
The device description explicitly states that the Cynosure SculpSure is a "diode laser system" with "main components" being a "console and four applicators that deliver the laser energy to the patient." This indicates it is a hardware-based device that uses software for control and operation, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "non-invasive lipolysis" and affecting the "appearance of visible fat bulges" and "lax tissue." These are aesthetic and physical treatments performed directly on the patient's body.
- Device Description: The device is described as a "diode laser system" that delivers "laser energy to subcutaneous tissue layers." This is a physical energy-based device, not a device that analyzes biological samples.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. The SculpSure device does not perform any such tests on biological samples.
While the device description mentions "image processing" and "ultrasound imaging" for evaluating treatment effectiveness, this is for assessing the results of the physical treatment on the patient's body, not for diagnosing a condition or analyzing a biological sample.
N/A
Intended Use / Indications for Use
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 49 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area. When using the petite mask for non-invasive lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area.
Product codes (comma separated list FDA assigned to the subject device)
PKT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen, flanks, back, thighs, submental area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A controlled clinical study was conducted to evaluate the safety and efficacy of treatment in the submental area for adipose tissue reduction using the petite mask.
A prospective, controlled study was conducted at 3 study centers to evaluate the safety and efficacy of the Cynosure SculpSure laser for the non-invasive fat reduction of the submental area, using the new petite mask (10.49cm²). 61 subjects enrolled in the study. Treatment effectiveness was assessed through blind evaluation of pre- and post- final treatment (12 week) photographs; significant change in 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 average, blind evaluators were able to identify 91% (53/58) of all post-treatment photograph. Reduction in adipose tissue was measured by ultrasound imaging at 12-week post follow up visit. Results showed a p-value of
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration".
January 3, 2019
Cynosure Amy Tannenbaum Regulatory Affairs Specialist III 5 Carlisle Road Westford, Massachusetts 01886
Re: K182741
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: September 27, 2018 Received: September 28, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/ofpmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer R. Stevenson -S3
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) K182741
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 49 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area. When using the petite mask for non-invasive lipolysis of the submental area, the device can also affect the appearance of lax tissue in the 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) |
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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.
| 807.92(a)(1) Submitter Information | |
|---|---|
| Applicant | Cynosure, Inc. |
| Address | 5 Carlisle Road |
| Westford, MA 01886 | |
| Phone Number | (978) 256-4200 |
| Fax Number | (978) 256-6556 |
| Establishment Registration Number | 1222993 |
| Contact Person | Amy Tannenbaum |
| Preparation Date | September 27, 2018 |
| 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 K171992, Zeltiq Coolsculpting K172144 |
| The predicate devices have not been subject to a design-related | |
| recall | |
| 807.92(a)(4) 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. | |
| 807.92(a)(5) Intended Use of the Device | |
| The 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 49 or less. | |
| The device is intended to affect the appearance of visible fat | |
| bulges in the abdomen, flanks, back, thighs, and submental area. | |
| When using the petite mask for non-invasive lipolysis of the | |
| submental area, the device can also affect the appearance of lax | |
| tissue in the submental area. |
4
807.92(a)(6) Summary of the Technological Characteristics of the Device Compared to the Predicate
| Proposed SculpSure | Cynosure SculpSure | Zeltiq Coolsculpting | |
|---|---|---|---|
| Laser System | Laser System | Device | |
| 510(k) Number | KPending | K171992 | K172144 |
| 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) | 1060 ±20 nm | ||
| (infrared) | N/A | ||
| Spot Size | 4 x 6 $cm²$ on each of | ||
| the Applicator heads | |||
| (up to four | |||
| applicators per body | |||
| treatment) | |||
| 14.28 $cm²$ (for | |||
| standard submental | |||
| mask) | |||
| 10.49 $cm²$ (for petite | |||
| submental mask) | 4 x 6 $cm²$ on each of | ||
| the Applicator heads | |||
| (up to four | |||
| applicators per body | |||
| treatment) | |||
| 14.28 $cm²$ (one | |||
| applicator head and | |||
| frame used for | |||
| Submental treatment) | 4.5 x 7 $cm²$ (2x) | ||
| approximate | |||
| Pulse Width (laser | |||
| ON time) | CW | CW | N/A |
| Power Density | Up to 1.4 W/ $cm²$ | ||
| (body) | |||
| Up to 3.06 W/ $cm²$ | |||
| (submental) | Up to 1.4 W/ $cm²$ | ||
| (body) | |||
| Up to 2.35 W/ $cm²$ | |||
| (submental) | N/A | ||
| Attachment to | |||
| patient | Belt (body treatment) | ||
| Headgear and straps | |||
| (submental treatment) | Belt (body treatment) | ||
| Headgear and straps | |||
| (submental treatment) | Belt | ||
| Voltage | 200-240V~, Single | ||
| Phase | 200-240V~, Single | ||
| Phase | N/A | ||
| Current | 20A | 20A | N/A |
5
807.92(b)(1) Non-clinical tests submitted
Electromagnetic compatibility and electrical safety was performed per standards IEC 60601-1, Ed 3.1, IEC 60601-1-2 Ed 4, IEC 60601-2-22, Ed 3.1, and IEC 60825-1 Ed 2. Software has been updated and validation was performed. 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 petite submental mask provides beam uniformity to the treatment area with +/- 15% specifications.
807.92(b)(2) Clinical tests submitted
A controlled clinical study was conducted to evaluate the safety and efficacy of treatment in the submental area for adipose tissue reduction using the petite mask.
A prospective, controlled study was conducted at 3 study centers to evaluate the safety and efficacy of the Cynosure SculpSure laser for the non-invasive fat reduction of the submental area, using the new petite mask (10.49cm²). The treatment techniques used and subsequent follow up schedule for the study were kept consistent between the three centers. 61 subjects enrolled in the study. 34 subjects had a BMI of less than 30, and 27 subjects had a BMI of 30 or higher. Each subject received up to 2 treatments with the petite mask in the submental area. There were 4 patients that received 1 treatment, and the rest received 2 treatments. Treatment effectiveness was assessed through blind evaluation of pre- and post- final treatment (12 week) photographs; significant change in 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. In addition, an analysis of the safety and adverse events will be conducted. On average, blind evaluators were able to identify 91% (53/58) of all post-treatment photograph. Reduction in adipose tissue was measured by ultrasound imaging at 12-week post follow up visit. Results showed a p-value of