(105 days)
There are no K/DEN numbers for predicate devices in the provided input.
Not Found.
No
The summary describes a laser lipolysis system with standard components and performance testing. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes
The intended use explicitly states "non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells," which describes a therapeutic effect on the body.
No
The device is intended for non-invasive lipolysis (fat removal), which is a therapeutic aesthetic procedure, not a diagnostic one.
No
The device description explicitly states it is a "diode laser system" with "a console and four applicators that deliver the laser energy to the patient," indicating it is a hardware device. While software verification and validation were performed, this is for software contained in the medical device, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic assthetic affect." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a "diode laser system" that delivers "laser energy to the patient." This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on a specimen.
The device is a therapeutic laser system used for aesthetic purposes, not a diagnostic tool that analyzes biological samples.
N/A
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 9, 2021
Rohrer Aesthetics, LLC Mark Rohrer President 105 Citation Court Birmingham, Alabama 35209
Re: K212331
Trade/Device Name: BodySculp Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use Regulatory Class: Class II Product Code: PKT Dated: October 7, 2021 Received: October 12, 2021
Dear Mark Rohrer:
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/cfdocs/cfpmn/pmn.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.
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya Assistant Director 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
Enclosure
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Indications for Use
510(k) Number (if known) K212331
Device Name BodySculp
Indications for Use (Describe)
The Bodysculp laser lipolysis system is intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic assthetic affect. This treatment is 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 BodySculp K212331
This 510(K) Summary of safety and effectiveness for the BodySculp System is submitted in accordance with the requirements of 21 CFR 807.92 and following guidance concerning the organization and content of a 510(K) summary.
Applicant:
| Applicant: | Rohrer Aesthetics, LLC |
|---|---|
| Address: | Rohrer Aesthetics, LLC |
| 105 Citation Court | |
| Birmingham, AL 35209 | |
| Contact Person: | Mr. Mark Rohrer |
| Telephone: | 205-356-1172 – phone |
| mrohrer@rohreraesthetics.com | |
| Preparation Date: | November 9, 2021 |
| Device Trade Name: | BodySculp |
| Product Code: | PKT |
| Regulation Number: | 21 CFR 878.5400 |
| Common Name: | Laser For Disruption Of Adipocyte Cells For Aesthetic Use |
| Legally Marketed Predicate | |
| Devices: | PowerSculp (Wuhan Lotuxs Technology Co, Ltd.) |
| Predicate 510(K) number: | K191068 |
| Regulatory Class: | Class II Prescription Use |
| Description of the BodySculp | |
| System | The BodySculp is a diode laser system. The main components of |
| BodySculp are a console and four applicators that deliver the laser | |
| energy to the patient. Electrically efficient semiconductors generate | |
| optical radiation (1060 nm) which issued to deliver laser energy to | |
| subcutaneous tissue layers. | |
| Intended use of BodySculp | |
| System | The Bodysculp laser lipolysis system is intended for non-invasive lipolysis |
| of the flank and abdomen to achieve disruption of adipocyte cells | |
| intended for non-invasive aesthetic use to achieve a desired aesthetic | |
| affect. This treatment is intended for individuals with a Body Mass Index | |
| (BMI) of 30 or less. | |
| Results of Clinical Study: | A human clinical study was not required as the device is identical to the |
| predicate device. |
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510(K) Summary BodySculp K212331
| Indications for Use Comparison: | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| The Bodysculp laser | |||
| lipolysis system is | |||
| intended for non- | |||
| invasive lipolysis of the | |||
| flank and abdomen to | |||
| achieve disruption of | |||
| adipocyte cells intended | |||
| for non-invasive | |||
| aesthetic use to achieve | |||
| a desired aesthetic | |||
| affect. This treatment is | |||
| intended for individuals | |||
| with a Body Mass Index | |||
| (BMI) of 30 or less. | The PowerSculp laser | ||
| lipolysis system is | |||
| intended for non- | |||
| invasive lipolysis of the | |||
| flank and abdomen to | |||
| achieve disruption of | |||
| adipocyte cells intended | |||
| for non-invasive | |||
| aesthetic use to achieve | |||
| a desired aesthetic | |||
| affect. This treatment is | |||
| intended for individuals | |||
| with a Body Mass Index | |||
| (BMI) of 30 or less. | Identical |
Technical Specifications Comparison:
| Item | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Laser Type | Diode Laser | Diode Laser | Same |
| Wavelength | 1060nm | 1060 ± 20nm | Same |
| Lipolysis method | Heat-assisted | Heat-assisted | Same |
| Spot Size | 4 × 8 cm² (A single | ||
| applicator | |||
| of four applicators) | 4 × 8 cm² (A single | ||
| applicator | |||
| of four applicators) | Same | ||
| Peak Power | 50W(per applicator) | 50W (per applicator) | Same |
| Power Density | Up to 0.7-1.7W/ cm² | Up to 0.7-1.7W/ cm² | Same |
| Pulse Width | CW | CW | Same |
| Power Supply | AC100-240V/50- | ||
| 60Hz(customizable) | AC100-240V, 50/60Hz, | ||
| 15A | Same | ||
| Peak Power | 50W (per applicator) | 50W (per applicator) | Same |
| Cooling | Contact Cooling | Contact Cooling | Same |
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510(K) Summary BodySculp K212331
| Performance Data: | The following performance data was provided in support of the substantial equivalence determination: |
|---|---|
| IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance | |
| IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility | |
| IEC 60601-2-22 Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment | |
| Software Verification and Validation Testing for Moderate Level of Concern per FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices | |
| An evaluation per ISO 10993-1 Evaluation of medical device – Part 1: Evaluation and testing within a risk management process was conducted. The evaluation determined that biocompatibility testing was not required because the materials and processes for the patient contacting material are identical to the predicate device and has been previously cleared by the FDA. | |
| Conclusion: | The BodySculp laser lipolysis system is substantially equivalent to its predicate device with same indications for use and same technological characteristics. The non-clinical data for the BodySculp laser lipolysis system supports the safety of the device. There are no new concerns about safety or efficacy. |