Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a laser lipolysis system and does not mention any AI or ML components or functionalities.

Therapeutic

Yes
The device is described as a "Hyperthermic Laser Lipolysis system" intended for "non-invasive lipolysis" to "reduce fat" and "breakdown the fat cells" for "body contouring." These actions are directly affecting the body's structure and function for a health-related purpose (fat reduction and body reshaping), which aligns with the definition of a therapeutic device.

Diagnostic

No
The device is described as a non-invasive laser lipolysis system intended for body contouring and fat reduction, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "1060nm Diode Hyperthermic Laser Lipolysis system" and applies a "1060nm wavelength laser," indicating it is a hardware-based device that uses laser technology for treatment.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "non-invasive lipolysis of the abdomen, flanks, back, and thighs" and to "affect the appearance of visible fat bulges." This describes a physical treatment applied to the body.
Device Description: The description details a "1060nm Diode Hyperthermic Laser Lipolysis system" that applies a laser to target adipose tissue. This is a physical device used for a therapeutic or aesthetic purpose.
Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.

The device described is a therapeutic or aesthetic medical device used for body contouring.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

PKT

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

abdomen, flanks, back, and thighs

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Not Found

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.

K182741

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

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ 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: +86-189 6489 4730

Fax: +86-21 51012882

E-mail: jeremy@belemed.com

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 (K182741) | Discussion |
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| PKT | Identical |
| 21 CFR 878.5400 | Identical |
| Class II | Identical |
product is
| Diode laser | Identical |
nm
| 1060nm±20 nm
| Identical |
| Heat-assisted | Identical |
* 6 cm² on each of
| 4 * 6 cm² on each of
| Equivalent |
| 14.28 cm² (for standard submental mask)
| |
| CW | Identical |
| Up to 1.4 W/ cm² (body)
| Similar |
| Belt | Identical |
16-4A , 50/60Hz. | AC200-240V, 50/60Hz, 20A | Equivalent |
| 30W (per applicator) | Equivalent |
| 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.