(86 days)
Not Found
No
The summary describes a laser lipolysis system with standard components and testing, with no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
No
The device is described as "intended for non-invasive aesthetic use to achieve a desired aesthetic effect," rather than for the treatment or diagnosis of a disease or condition.
No
The device description states its intended use is 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," which describes a treatment rather than a diagnostic function.
No
The device description explicitly states it is a "diode laser system" with physical components like a console and applicators, indicating it is a hardware device, not software-only.
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 use". This describes a procedure performed on the body for aesthetic purposes, not a test performed on a sample taken from the body to diagnose or monitor a medical condition.
- Device Description: The device is a laser system that delivers energy to subcutaneous tissue. This is a therapeutic or aesthetic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 a desired a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.
Product codes (comma separated list FDA assigned to the subject device)
PKT
Device Description
The Powersculp laser lipolysis system is a diode laser system. Electrically efficient semiconductors generate optical radiation (1060 mm) which is used to deliver laser energy to subcutaneous tissue layers. The Powersculp laser lipolysis system is capable of peak powers of 50W. The main components of Powersculp laser lipolysis system are a console and four applicators.
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 (Part 21 CFR 801 Subpart D)
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)
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.
Clinical Tests Submitted: According to "8. Clinical Testing" of "Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use", and operating instruction and "7. Summary of Substantial Equivalence" submitted of the proposed device, the proposed device PSP050 is Substantially Equivalent (SE) to the predicate device, includes: indication for use, design (such as operating theory, structure and main component, software control), technology (such as laser type, lipolysis method, wavelength, power width, cooling method, attachment to patient), the non-clinical tests complied with the requirements of relevant recognized standards, and passed the bench tests (such as performance tests, storage condition tests), so Lotuxs belives that the proposed device Powersculp laser lipolysis system PSP050 does not need to carry out clinical tests, and the clinical study data that have been the legally marketed device can be used for reference.
Conclusions drawn from clinical and non-clinical tests submitted: Lotuxs believes that Powersculp laser lipolysis system PSP050 is substantially equivalent to its predicate devices with same indications for use, similar technological characteristics. The non-clinical data for Powersculp laser lipolysis system PSP050 supports the safety of the device and the biocompatibility, hardware and software verification and validation demonstrate that the Powersculp laser lipolysis system PSP050 should perform as intended in the specified use conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in a sans-serif font, with "FDA" in a blue square and the rest of the text in blue.
July 17, 2019
Wuhan Lotuxs Technology Co., Ltd. % Jinghua Zhou Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou, China 511660
Re: K191068
Trade/Device Name: Powersculp laser lipolysis system Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System for Aesthetic Use Regulatory Class: Class II Product Code: PKT Dated: April 22, 2019 Received: April 22, 2019
Dear Jinghua Zhou:
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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for
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.
Neil Ogden 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) K191068
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 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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Section 5 - 510(k) Summary
Date of Summary Preparation: April 15, 2019
1. Submitter's Identifications
Submitter's Name: Wuhan Lotuxs Technology Co., Ltd. Address: 5F, E2 Building, NO 999 Gaoxin Avenue, Future City, East lake High-Tech Development Zone, Wuhan 430206, China Contact Person: Na Wu Contact Title: QA Manager Contact Email Address: na.wu@lotuxs.com Telephone: +86-27-87619668 Fax: +86-27-87515058
2. Correspondent's Identifications
Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 215, Huaming Building, Chebei Road, Guangzhou, P.R. China ZIP Code: 511660 Contact Person: Jinghua Zhou Contact Title: Regulation Control Manager Contact E-mail Address: admanzhou@126.com Telephone: +86-20-82329549 Fax: +86-20-82329549
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: PSP050 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: K160470 SculpSure Secondary predicate device: K150230 Sculpsure
5. Device Description
The Powersculp laser lipolysis system is a diode laser system. Electrically efficient semiconductors generate optical radiation (1060 mm) which is used to deliver laser
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energy to subcutaneous tissue layers. The Powersculp laser lipolysis system is capable of peak powers of 50W. The main components of Powersculp laser lipolysis system are a console and four applicators.
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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7. Summary of Substantial Equivalence
Table 1
| Proposed device | Primary predicate device | Secondary predicate device | Comparison | |
|---|---|---|---|---|
| 510k Number | ------ | K160470 | K150230 | ------ |
| Product Code | PKT | PKT | PKT | Same |
| Proprietary Name | Powersculp laser lipolysis system | Sculpsure | Sculpsure | ------ |
| Model | PSP050 | / | / | ------ |
| Manufacturer | Wuhan Lotuxs Technology Co., Ltd. | Cynosure, Inc. | Cynosure, Inc. | ------ |
| 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. | The Cynosure SculpSure is a diode laser system intended for noninvasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen and flanks. | The Cynosure SculpSure is intended for non-invasive lipolysis of the flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less. | Same |
| The indications for use of the proposed device are same as those of predicate device K160470 and K150230. | ||||
| Operating theory | The Powersculp laser lipolysis system is a diode laser system. Electrically efficient | The Cynosure SculpSure is a diode laser system. The main components of | The Cynosure SculpSure is a diode laser system. Electrically efficient | Same |
| Although there are differences in expression | ||||
| semiconductors generate optical radiation (1060 nm) which is used to deliver laser energy to subcutaneous tissue layers. The Powersculp laser lipolysis system is capable of peak powers of 50W. The main components of Powersculp laser lipolysis system are a console and four applicators. | SculpSure are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate opticalradiation (1060 nm) which is used to deliver laser energy tosubcutaneous tissue layers. | semiconductors generate optical radiation (1064 nm) which is used to directly irradiate the skin's surface. The Sculpsure is intended for noninvasive lipolysis of the flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. | among the three devices, the technical principles are essentially the same. | |
| Structure and main components | The main components of Powersculp laser lipolysis system are a console and four applicators. | The main components of SculpSure are a console and four applicators. | The main components of SculpSure are a console and applicator. | Same |
| The main components of the proposed device are same as those of the primary predicate device K160470. | ||||
| Laser type | diode laser | diode laser | diode laser | Same |
| Lipolysis method | Heat-assisted | Heat-assisted | Heat-assisted | Same |
| Wavelength | 1060nm±20 nm (infrared) | 1060 ±20 nm (infrared) | 1064nm | Same |
| Spot size | 4 × 8 cm² (A single applicator of four applicators) | 4 × 6 cm² on each of the applicator heads (4X) | 4 × 6 cm² (3X) | Similar |
| The amount of applicator is same between the primary predicate device K160470 and the proposed device. | ||||
| Pulse Width (laser | ||||
| ON time) | CW | CW | CW | The spot size of applicator |
| does not affect the safety | ||||
| and effectiveness. | ||||
| Power density | Up to 0.7-1.7W/ cm² | Up to 1.4 W/cm² | 1.7W/ cm² | Similar |
| The power density of the | ||||
| proposed device is | ||||
| customizable, and the | ||||
| maximum power density is | ||||
| same as the secondary | ||||
| predicate device K150230, | ||||
| so this defference is not | ||||
| affect safety and | ||||
| effectiveness. | ||||
| Power supply | AC100-240V, 50/60Hz, 15A | 200-240V~, Single Phase, | ||
| 20A | 120V, 20A | Similar | ||
| The power supply is | ||||
| different, not affect safety | ||||
| and effectiveness. | ||||
| Peak power | 50W (per applicator) | 30W (per applicator) | 40W (per applicator) | Similar |
| The peak power is different, | ||||
| which related to power | ||||
| density and spot size. The | ||||
| difference does not affect | ||||
| safety and effectiveness. | ||||
| Cooling | Contact cooling | Contact cooling | Contact cooling | Same |
| Attachment to | ||||
| patient | belt | belt | belt | Same |
| Software control | Yes | Yes | Yes | Same |
| Electromagnetic | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| compatibility and | ANSI AAMI ES60601-1 | ANSI AAMI ES60601-1 | ANSI AAMI ES60601-1 | |
| electrical safefy | IEC 60825-1 | IEC 60825-1 | IEC 60825-1 | |
| compliance | IEC 60601-2-22 | IEC 60601-2-22 | IEC 60601-2-22 | |
| Discussion for | ||||
| Substantially | ||||
| Equivalent (SE) | The proposed device PSP050 has the same as the predicate device: indications for use, operating theory, structure and | |||
| main components, laser type, lipolysis method, wavelength, power width, cooling method, attachment to patient. The | ||||
| differences only exist in such contents: spot size, power density, power supply, peak power that both can be controlled in | ||||
| range of application. These minor differences between proposed device and predicate device raise no new issue of safety | ||||
| and effectiveness. According to the non-clinical test results, the proposed devices are as safe, as effective and perform as | ||||
| well as the predicate device. | ||||
| So the proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. |
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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 Submitted:
According to "8. Clinical Testing" of "Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use", and operating instruction and "7. Summary of Substantial Equivalence" submitted of the proposed device, the proposed device PSP050 is Substantially Equivalent (SE) to the predicate device, includes: indication for use, design (such as operating theory, structure and main component, software control), technology (such as laser type, lipolysis method, wavelength, power width, cooling method, attachment to patient), the non-clinical tests complied with the requirements of relevant recognized standards, and passed the bench tests (such as performance tests, storage condition tests), so Lotuxs belives that the proposed device Powersculp laser lipolysis system PSP050 does not need to carry out clinical tests, and the clinical study data that have been the legally marketed device can be used for reference.
10. Conclusions drawn from clinical and non-clinical tests submitted:
Lotuxs believes that Powersculp laser lipolysis system PSP050 is substantially equivalent to its predicate devices with same indications for use, similar technological characteristics. The non-clinical data for Powersculp laser lipolysis system PSP050 supports the safety of the device and the biocompatibility, hardware and software verification and validation demonstrate that the Powersculp laser lipolysis system PSP050 should perform as intended in the specified use conditions.
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