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 a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.

Device Description

PowerSculp laser lipolysis system is a diode laser system that emits laser radiation centered at 1064nm in order to achieve non-invasive laser lipolysis. Main components of the device include the laser console with display and controls, and four cooled laser applicators that attach to frames and a belt that is attached to the person being treated. The device is powered by an alternating current electrical power source.

AI/ML Overview

The provided document, a 510(k) Premarket Notification summary for the Lotuxs Medtech (Suzhou) Co., Ltd. Powersculp laser lipolysis system, explicitly states:

"No clinical tests were provided for this pre-market notification." (Page 7, Section 9. Clinical Tests)

Therefore, based on the provided text, there is no study that proves the device meets acceptance criteria, as no clinical studies were submitted. The acceptance criteria and the study details requested cannot be extracted from this document because such a study was not performed or submitted as part of this 510(k) application.

The 510(k) clearance for this device was based on non-clinical tests demonstrating substantial equivalence to a predicate device (K191068 Powersculp laser lipolysis system), not on a clinical effectiveness study.

Here's an breakdown of the information that can be extracted from the provided document, in relation to the prompt's requests:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied by Non-Clinical Testing): The acceptance criteria for this 510(k) submission are based on demonstrating that the proposed device performs as intended and is as safe and effective as the predicate device through non-clinical testing. This primarily involved meeting engineering specifications and safety standards.
- Software verification and validation: Software performs as intended.
- Power Output: Meets specification.
- Electromagnetic Compatibility and Electrical Safety: Complies with IEC 60601-1-2, ANSI AAMI ES60601-1, IEC 60601-2-22, and IEC 60825-1.
- Biocompatibility: Patient contacting materials assessed per ISO 10993-1 and found to be biocompatible.
Reported Device Performance (from Non-Clinical Tests): The document confirms that the device met these criteria:
- Software verification and validation performed, demonstrated software performs as intended.
- Testing confirmed power output meets specification.
- EMC and electrical safety testing performed, results confirmed the device meets the standards.
- All patient contacting materials assessed and found biocompatible.

2. Sample sized used for the test set and the data provenance:

Not applicable as no clinical test set was used. Non-clinical tests would involve specific units of the device and testing materials, but these are not analogous to patient sample sizes for clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as no clinical test set requiring expert ground truth was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable as no clinical test set was used.

5. 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 as no clinical effectiveness study, specifically an MRMC study, was conducted or submitted. This device is not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a laser lipolysis system, not an algorithm, so standalone performance in the context of an algorithm is irrelevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable for clinical ground truth as no clinical studies were performed. For the non-clinical tests, "ground truth" would be the engineering specifications and safety standards against which the device performance was measured.

8. The sample size for the training set:

Not applicable as no AI/machine learning model requiring a training set was involved.

9. How the ground truth for the training set was established:

Not applicable as no AI/machine learning model requiring a training set was involved.

In summary, the 510(k) clearance for the Powersculp laser lipolysis system (K211402) was based solely on non-clinical testing and a demonstration of substantial equivalence to a predicate device, not on clinical performance data or studies involving human subjects to establish effectiveness for the indicated use.

Summary

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July 30, 2021

Lotuxs Medtech (Suzhou) Co., Ltd. Na Wu OA Manager RM301, NW-06, Nanopolis Suzhou, 99 Jinji Lake Avenue, Suzhou Industry Suzhou, Jiangsu 215123 China

Re: K211402

Trade/Device Name: Powersculp laser lipolysis system Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use 878.5650 Regulatory Class: Class II Product Code: PKT Dated: May 6, 2021 Received: May 6, 2021

Dear Na Wu:

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)

K211402

Device Name Powersculp laser lipolysis system

Indications for Use (Describe)

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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Lotuxs Medtech (Suzhou) Co., Ltd.

Section 5 - 510(k) Summary

Date of Summary Preparation: April 30, 2021

1. Submitter's Identifications

Submitter's Name: Lotuxs Medtech (Suzhou) Co., Ltd. Address: RM301, NW-06, Nanopolis Suzhou, 99 Jinji Lake Avenue, Suzhou Industry Park, Suzhou 215123, China Contact Person: Na Wu Contact Title: QA Manager Contact Email Address: na.wu@lotuxs.com Telephone: +86-0512-6288 0553

2. Correspondent's Identifications

Correspondent's Name: Lotuxs Medtech (Suzhou) Co., Ltd. Address: RM301, NW-06, Nanopolis Suzhou, 99 Jinji Lake Avenue, Suzhou Industry Park, Suzhou 215123, China ZIP Code: 215123 Contact Person: Na Wu Contact Title: QA Manager Contact E-mail Address: na.wu@lotuxs.com Telephone: +86-0512-6288 0553

3. Name of the Device

Device Classification Name: Laser for disruption of adipocyte cells for aesthetic use Product Name: Low level laser system for aesthetic use Trade Name: Powersculp laser lipolysis system Model: PSP100 Classification Panel: General & Plastic Surgery Product Code: PKT Regulation Number: 21 CFR 878.5400 Device Classification: Class II

4. The Predicate Devices

Primary Predicate device: K191068 Powersculp laser lipolysis system

5. Device Description

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Lotuxs Medtech (Suzhou) Co., Ltd.

treated. The device is powered by an alternating current electrical power source.

6. Intended Use of Device

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.

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K211402

Lotuxs Medtech (Suzhou) Co., Ltd.

7. Device Comparison Table

Table 1

	Proposed device	Primary predicate device	Comparison
510k Number	K211402	K191068	-------
Product Code	PKT	PKT	Same
Proprietary Name	Powersculp laser lipolysis system	Powersculp laser lipolysis system	Same
Model	PSP100	PSP050	-------
Manufacturer	Lotuxs Medtech (Suzhou) Co., Ltd.	Wuhan Lotuxs Technology Co., Ltd.	-------
Indications for use	The PowerSculp laser lipolysis system is intended for aesthetic use, non-invasive lipolysis of the flank and abdomen to disrupt adipocyte cells thus achieving desired aesthetic effect. 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.	Same
Structure and maincomponents	The main components of Powersculp laser lipolysis system are a console and four applicators.	The main components of Powersculp laser lipolysis system are a console and four applicators.	Same
Laser type	diode laser	diode laser	Same
Wavelength	1064nm±20 nm (infrared)	1060 ±20 nm (infrared)	SimilarThe wavelength of
			proposed device isslightly larger thanthat of predicatedevice. It does notaffect safety andeffectiveness.
Spot size	4 x 8 cm2 (A single applicator of fourapplicators)	4 x 8 cm2 (A single applicator of fourapplicators)	Same
Pulse Width (laserON time)	CW	CW	Same
Power density	Up to 0.7-1.7W/ cm2	Up to 0.7-1.7W/ cm2	Same
Power supply	AC100-240V, 50/60Hz, 15A	AC100-240V, 50/60Hz, 15A	Same
Peak power	50W (per applicator)	50W (per applicator)	Same
Cooling	Contact cooling	Contact cooling	Same
Attachment topatient	belt	belt	Same
Software control	Yes	Yes	Same
Electromagneticcompatibility andelectrical safetycompliance	IEC 60601-1-2ANSI AAMI ES60601-1IEC 60825-1IEC 60601-2-22	IEC 60601-1-2ANSI AAMI ES60601-1IEC 60825-1IEC 60601-2-22	Same

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K211402

Lotuxs Medtech (Suzhou) Co., Ltd.

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8. Non-Clinical Tests Submitted:

Software verification and validation was performed, and it was demonstrated that the software performs as intended according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Testing confirmed that the power output meets specification. Electromagnetic compatibility and electrical safety testing was performed per standards ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22 and IEC 60825-1. Results confirmed the device meets the standards. All patient contacting materials were assessed as per ISO 10993-1 and found to be biocompatible.

9. Clinical Tests:

No clinical tests were provided for this pre-market notification.

10. Conclusions drawn from clinical and non-clinical tests submitted:

The proposed PowerSculp device utilizes technological characteristics that are the same or are similar to the K191068 predicate device. The proposed device's technological characteristics do not raise new types of questions regarding safety and effectiveness, and the performance testing that was done supports that the proposed device can be used safety and effectively for the proposed indication for use above. Based on the comparison and analysis above, the proposed device is considered to be Substantially Equivalent (SE) to the predicate device.

Regulation Number and Section

§ 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.