(85 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on the laser technology and hardware components. There is no mention of any software features that would suggest AI/ML is used for image processing, treatment planning, or any other function.
Yes.
The device 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," which is a therapeutic purpose.
No
The device description and intended use clearly state that the PowerSculp laser lipolysis system is for non-invasive lipolysis to achieve an aesthetic effect, not for diagnosing any medical condition.
No
The device description explicitly lists hardware components such as a laser console, display, controls, and four cooled laser applicators. The performance studies also include testing related to power output, electromagnetic compatibility, and electrical safety, which are hardware-related aspects.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive a desired aesthetic affect." This describes a procedure performed directly on the patient's body for aesthetic purposes.
- Device Description: The device is a "diode laser system" that emits laser radiation. This is a physical device used for treatment, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: IVD devices are 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 of biological samples.
The description clearly indicates a therapeutic device used for a cosmetic procedure, not a diagnostic device used for analyzing biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
PKT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
flank and abdomen
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)
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. No clinical tests were provided for this pre-market notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows 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.
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)
Device Name Powersculp laser lipolysis system
Indications for Use (Describe)
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.
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
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
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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 main | |||
| components | 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) | Similar |
| The wavelength of | |||
| proposed device is | |||
| slightly larger than | |||
| that of predicate | |||
| device. It does not | |||
| affect safety and | |||
| effectiveness. | |||
| Spot size | 4 x 8 cm2 (A single applicator of four | ||
| applicators) | 4 x 8 cm2 (A single applicator of four | ||
| applicators) | Same | ||
| Pulse Width (laser | |||
| ON 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 to | |||
| patient | belt | belt | Same |
| Software control | Yes | Yes | Same |
| Electromagnetic | |||
| compatibility and | |||
| electrical safety | |||
| compliance | IEC 60601-1-2 | ||
| ANSI AAMI ES60601-1 | |||
| IEC 60825-1 | |||
| IEC 60601-2-22 | IEC 60601-1-2 | ||
| ANSI AAMI ES60601-1 | |||
| IEC 60825-1 | |||
| IEC 60601-2-22 | Same |
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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.