Diode Laser Body Sculpture Systems

K231131 · Shanghai Bele Medical Technology Co.,Ltd · PKT · Jun 22, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K231131
• Device Name: Diode Laser Body Sculpture Systems
• Applicant: Shanghai Bele Medical Technology Co.,Ltd
• Product Code: PKT · General, Plastic Surgery
• Decision Date: Jun 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This product is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs 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, flanks, back, and thighs.

Device Story

Diode Laser Body Sculpture System (BL-A10) is a 1060nm hyperthermic laser lipolysis device for non-invasive body contouring. It uses infrared laser energy to target and heat adipose tissue, inducing fat cell breakdown to reduce fat bulges in abdomen, flanks, back, and thighs. The system utilizes up to four applicator heads attached to the patient via a belt, incorporating contact cooling for safety. It is intended for use by healthcare professionals in a clinical setting. The provider positions applicators on target areas; the device delivers continuous wave (CW) laser energy to heat fat cells while protecting the skin surface via contact cooling. This process reduces the number of fat cells in the treated area, resulting in body contouring benefits for the patient.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1), and biocompatibility (ISO 10993-1).

Technological Characteristics

1060nm (±20nm) infrared diode laser; heat-assisted lipolysis; CW pulse width; 35W peak power per applicator; 4x6 cm² spot size; contact cooling; belt-based applicator attachment; AC110-240V power. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1. Biocompatibility per ISO 10993-1 (cytotoxicity, irritation, sensitization).

Indications for Use

Indicated for non-invasive lipolysis of abdomen, flanks, back, and thighs in individuals with BMI ≤ 30 to reduce visible fat bulges.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• SculpSure (K182741)

Submission Summary (Full Text)

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June 22, 2023

Shanghai Bele Medical Technology Co.,Ltd Jeremy Li General Manager Room 402, 4F, Building 1, No.3255 Shengang Road, Songjiang District Shanghai, Shanghai 201600 China

Re: K231131

Trade/Device Name: Diode Laser Body Sculpture Systems Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use Regulatory Class: Class II Product Code: PKT Dated: March 24, 2023 Received: April 21, 2023

Dear Jeremy Li:

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.

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

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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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, clear font. The text is horizontally oriented and appears to be the primary focus of the image. The background is plain, ensuring the text is easily readable.

Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K231131

Device Name Diode Laser Body Sculpture Systems

Indications for Use (Describe)

This product is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs 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, flanks, back, and thighs.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 10pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Section 3-510(k) summary K231131

# l Submitter

SHANGHAI BELE MEDICAL TECHNOLOGY CO.,LTD

Room 402, 4F, Building 1, NO.3255 Shengang Road, Songjiang District, Shanghai, China

### Contact Person

Jeremy Li

General manager

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

# II Proposed Device

| Trade Name of Device: | Diode Laser Body Sculpture Systems |
|-----------------------|------------------------------------------|
| Common name: | Low Level Laser System for Aesthetic Use |
| Regulation Number: | 21 CFR 878.5400 |
| Regulatory Class: | Class II |
| Product code: | PKT |
| Review Panel: | General & Plastic Surgery |

### III Predicate Devices

| 510(k) Number: | K182741 |
|-----------------|------------------------------------------|
| Trade name: | SculpSure |
| Common name: | Low Level Laser System for Aesthetic Use |
| Classification: | Class II |
| Product Code: | PKT |
| Manufacturer | Cynosure |

# IV Device description

The BL-A10 is a 1060nm Diode Hyperthermic Laser Lipolysis system and is the latest technology for non-invasive body contouring. It applies a 1060nm wavelength laser to target the adipose tissue to reduce fat in areas such as flank and abdomen.

The purpose of the device is to breakdown the fat cells in the target area and in doing so contour the body and reduce the number of fat cells in that area. It is designed to meet international safety and performance standards.

# V Indication for use

This product is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs 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, flanks, back, and thighs.

# VI Comparison of technological characteristics with the predicate devices

| Item | Proposed device | Predicate device<br>(K182741) | Discussion |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | PKT | PKT | Identical |
| Regulation No. | 21 CFR 878.5400 | 21 CFR 878.5400 | Identical |
| Class | Class II | Class II | Identical |
| Indication for use | This product is<br>intended for non-<br>invasive lipolysis of<br>the abdomen, flanks,<br>back, and thighs in<br>individuals with a<br>Body Mass Index<br>(BMI) of 30 or less.<br>The device is<br>intended to affect the<br>appearance of visible<br>fat bulges in the<br>abdomen, flanks,<br>back, and thighs. | The Cynosure<br>SculpSureTM is<br>intended for non-<br>invasive lipolysis of<br>the abdomen, flanks,<br>back, and thighs in<br>individuals with a<br>Body Mass Index<br>(BMI) of 30 or less.<br>In addition, the<br>device is intended for<br>non-invasive lipolysis<br>of the submental<br>area in individuals<br>with a BMI of 49 or<br>less. The device is<br>intended to affect the<br>appearance of visible<br>fat bulges in the<br>abdomen, flanks,<br>back, thighs and<br>submental area.<br>When using the<br>petite mask for non-<br>invasive lipolysis of<br>the submental area,<br>the device can also<br>affect the<br>appearance of lax<br>tissue in the<br>submental area. | Equivalent |
| Laser type | Diode laser | Diode laser | Identical |
| Wavelength | 1060nm±20 nm<br>(infrared) | 1060nm±20 nm<br>(infrared) | Identical |
| Lipolysis method | Heat-assisted | Heat-assisted | Identical |
| Spot size | 4 * 6 cm² on each of<br>the Applicator heads<br>(up to four<br>applicators per body<br>treatment) | 4 * 6 cm² on each of<br>the Applicator heads<br>(up to four<br>applicators per body<br>treatment) | Equivalent |
| | | 14.28 cm² (for standard submental mask)<br>10.49 cm2 (for petite submental mask) | |
| Pulse width | CW | CW | Identical |
| Power density | 0.6~1.6W/cm² | Up to 1.4 W/ cm² (body)<br>Up to 3.06 W/ cm² (submental) | Similar |
| Attachment to patient | Belt | Belt | Identical |
| Voltage | AC110-240V, 16-4A , 50/60Hz. | AC200-240V, 50/60Hz, 20A | Equivalent |
| Peak power | 35W (per applicator) | 30W (per applicator) | Equivalent |
| Cooling | Contact cooling | Contact cooling | Identical |

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# VII Non-Clinical Testing

A series of tests have been performed to verity that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:

#### Electrical safety and electromagnetic compatibility

- IEC 60601-1 : 2005+A1 : 2012+A2 : 2020 / EN 60601-1: 2006+A1: ● 2013+A12:2014+A2:2021 Medical electrical equipment. General requirements for basic safety and essential performance
- IEC60601-1-2:2014+A1:2020 / EN 60601-1-2:2015+A1:2021 Medical electrical equipment - part 1-2 General requirements for basic - safety - and - performance -Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-2-22:2019/EN 60601-2-22:2020 Medical electrical equipment - part 2-22: Particular requirements for basic essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1:2014/EN 60825-1:2014 Safety of laser products-Part 1:Equipment classification and requirements

### Biocompatibility Evaluation:

Per FDA's Biocompatibility Guidance issued on September 04, 2020 and with regard to Table A.1 Evaluation Tests for consideration in ISO, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" " the following tests performed on the material which contacts with human for Biocompatibility:

- Cytotoxicity;
- Skin irritation;

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● Skin Sensitization.;

# VIII Clinical Testing

lt is not applicable.

# IX Conclusion

Base on the performance testing and validation studies that the subject device is substantially equivalent to the predicate device.