(105 days)
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.
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.
The provided document is a 510(k) summary for the BodySculp device, which is a low-level laser system for aesthetic use. It details the device, its intended use, and a comparison to a legally marketed predicate device (PowerSculp) to demonstrate substantial equivalence.
However, the document explicitly states that "A human clinical study was not required as the device is identical to the predicate device." This means there isn't a study proving the device meets specific acceptance criteria for performance related to its intended aesthetic effect in the way you're asking, i.e., through a clinical trial with human subjects.
Instead, the acceptance criteria and performance data provided in this 510(k) are related to safety, electrical compatibility, and software validation, demonstrating that the device itself is safe and functions as intended, and is substantially equivalent to a device already cleared for market. The clinical effectiveness for aesthetic outcomes relies on the predicate device's prior clearance.
Therefore, for your specific request regarding acceptance criteria and performance related to the aesthetic claims of the device (disruption of adipocyte cells, aesthetic affect), the information is not available in this document because a clinical study for these outcomes was not performed for BodySculp.
Here's a breakdown of what is available in the document regarding "acceptance criteria" through non-clinical performance data:
Acceptance Criteria and Reported Device Performance (Non-Clinical)
Since a human clinical study for efficacy was not conducted for the BodySculp device, the "acceptance criteria" and "reported device performance" in this context refer to the non-clinical performance data supporting the device's safety and functional equivalence to the predicate.
| Acceptance Criteria Category | Specific Standards/Tests | Reported Device Performance (Compliance) |
|---|---|---|
| Electrical Safety | IEC 60601-1 Test for Medical Electrical equipment: General Requirements for basic safety and essential performance | Performed: The test was performed. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility | Performed: The test was performed. |
| Laser Specific Safety & Performance | IEC 60601-2-22 Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment | Performed: The test was performed. |
| Software Verification & Validation | 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 | Performed: The testing was performed per FDA guidance. |
| Biocompatibility | ISO 10993-1 Evaluation of medical device – Part 1: Evaluation and testing within a risk management process (specifically, evaluation of patient-contacting materials) | Not Required (Evaluation Conducted): An evaluation per ISO 10993-1 was conducted. It was determined that biocompatibility testing was not required because the materials and processes for the patient-contacting material are identical to the predicate device and had been previously cleared by the FDA. This indicates that the predicate's biocompatibility data serves as the "performance" for this device's materials. |
| Equivalence to Predicate Device (Indications) | 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. | Identical: The indications for use are identical to the predicate device (PowerSculp). |
| Equivalence to Predicate Device (Technology) | Laser Type, Wavelength, Lipolysis method, Spot Size, Peak Power, Power Density, Pulse Width, Power Supply, Cooling mechanism. | Same/Similar: The BodySculp device has the same laser type (Diode Laser), wavelength (1060nm), lipolysis method (Heat-assisted), spot size (4x8 cm²), peak power (50W per applicator), power density (0.7-1.7W/cm²), pulse width (CW), power supply (AC100-240V/50-60Hz), and cooling (Contact Cooling) as the predicate device. |
Study Details (Based on the provided document)
As previously stated, a human clinical study was not required or conducted for the BodySculp device itself, as per the FDA 510(k) summary, because it was deemed substantially equivalent to a predicate device already on the market. Therefore, most of the following points cannot be answered from this document.
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Sample size used for the test set and the data provenance: Not applicable, as no dedicated clinical test set was required or used for this device's 510(k) clearance for aesthetic efficacy. The "test set" in the document refers to the device itself being tested against electrical safety and software standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human subject clinical ground truth was established for this device. Ground truth for the non-clinical tests (e.g., electrical safety) is typically established by engineering standards and test procedures, not expert consensus on medical images or outcomes.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no human subject clinical test set requiring adjudication was used.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser lipolysis system, not an AI-assisted diagnostic or imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm for diagnostic performance. Its "standalone" performance refers to its ability to meet engineering and safety standards.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical performance data, the "ground truth" implicitly used is compliance with established international and FDA-recognized standards for electrical safety, electromagnetic compatibility, laser safety, and software development. For the intended use and technological characteristics, the "ground truth" for substantial equivalence is the predicate device's cleared status and specifications.
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The sample size for the training set: Not applicable. This device does not use an AI/machine learning model trained on data for its primary function.
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How the ground truth for the training set was established: Not applicable.
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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, LLC105 Citation CourtBirmingham, AL 35209 |
| Contact Person: | Mr. Mark Rohrer |
| Telephone: | 205-356-1172 – phonemrohrer@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 PredicateDevices: | PowerSculp (Wuhan Lotuxs Technology Co, Ltd.) |
| Predicate 510(K) number: | K191068 |
| Regulatory Class: | Class II Prescription Use |
| Description of the BodySculpSystem | The BodySculp is a diode laser system. The main components ofBodySculp are a console and four applicators that deliver the laserenergy to the patient. Electrically efficient semiconductors generateoptical radiation (1060 nm) which issued to deliver laser energy tosubcutaneous tissue layers. |
| Intended use of BodySculpSystem | The Bodysculp laser lipolysis system is intended for non-invasive lipolysisof the flank and abdomen to achieve disruption of adipocyte cellsintended for non-invasive aesthetic use to achieve a desired aestheticaffect. 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 thepredicate device. |
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510(K) Summary BodySculp K212331
| Indications for Use Comparison: | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| The Bodysculp laserlipolysis system isintended for non-invasive lipolysis of theflank and abdomen toachieve disruption ofadipocyte cells intendedfor non-invasiveaesthetic use to achievea desired aestheticaffect. This treatment isintended for individualswith a Body Mass Index(BMI) of 30 or less. | The PowerSculp laserlipolysis system isintended for non-invasive lipolysis of theflank and abdomen toachieve disruption ofadipocyte cells intendedfor non-invasiveaesthetic use to achievea desired aestheticaffect. This treatment isintended for individualswith 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 singleapplicatorof four applicators) | 4 × 8 cm² (A singleapplicatorof 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. |
§ 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.