Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser-based device for fat reduction and does not mention any AI or ML components in its operation or intended use.

Therapeutic

Yes.
The device is intended for non-invasive lipolysis to affect the appearance of visible fat bulges, which is a therapeutic purpose.

Diagnostic

No

The device is described as a body slimming and shaping machine that uses a laser for non-invasive lipolysis and fat decomposition. Its purpose is to affect the appearance of visible fat bulges and achieve body contouring, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "1060nm laser body slimming machine" and uses "1060mm wavelength laser penetration," indicating it is a hardware device that emits a laser.

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 is for non-invasive lipolysis (fat reduction) of specific body areas. This is a therapeutic or aesthetic procedure performed on the body, not a diagnostic test performed on samples taken from the body.
Device Description: The description details a laser system that targets and heats fat cells within the body. This is a physical intervention, not a method for analyzing biological samples.
Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic purposes, or the use of reagents or assays typically associated with IVD devices.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to physically alter tissue within the body for cosmetic or therapeutic purposes related to fat reduction.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

1060mm laser body slimming machine 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, flank, back, and thighs.

Product codes

PKT

Device Description

The 1060nm laser body slimming machine is an ultra-thermal laser fat decomposition system that uses the latest technology for non-invasive body shaping. It uses 1060mm wavelength laser penetration to target adipose tissue, selectively heats fat cells, and reduces the number of fat cells in the area through blood and lymph metabolism to achieve shaping the purpose of body contouring. It is a new generation of safe and effective way to lose weight.

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)

No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K201731

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 contains 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.

HeBei JT Medical Co., Ltd. % Gina Lian General Manager Beijing STYH Medical Technology Service Co. Ltd. No.18, Jianshe Road, Kaixuan Street, Liangxiang Town, Fangshan District Beijing, Beijing 102488 China

Re: K240658

Trade/Device Name: 1060nm laser body slimming machine Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use Regulatory Class: Class II Product Code: PKT Dated: March 3, 2024 Received: March 8, 2024

Dear Gina Lian:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Digitally signed by Yan Fu -S
Date: 2024.05.13 14:09:57
Yan Fu -S
-04'00'

for

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & Infection Control Devices, Office of Product Evaluation and Quality

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Enclosure

3

Indications for Use

510(k) Number (if known) K240658

Device Name

1060nm laser body slimming machineModel: RZ-01

Indications for Use (Describe)

1060mm laser body slimming machine 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, flank, 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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510(k) Summary

K240658

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: __K240658

1. Date of Preparation
  5/13/2024
1. Sponsor
  HeBei JT Medical Co., Ltd. C12 Hegu Industrial Park, Chaoyang Road, Development Zone ZhuoZhou city Establishment Registration Number: Not yet registered or the Number Contact Person: Karen Liu Position: Sales manager Tel: +86-13911459627 Fax:86-10-5721-2057 Email: 919309354@qq.com
1. Submission Correspondent
  Ms. Gina Lian

Beijing STYH Medical Technology Service Co. Ltd.

No.18, Jianshe Road, Kaixuan Street, Liangxiang Town, Fangshan District,102488 Beijing, China. Tel: +86-13311543099 Email: 409308721@qq.com

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4. Identification of Subject Device

Trade Name: 1060nm laser body slimming machine Common Name: laser for disruption of adipocyte cells for aesthetic use; Model(s): RZ-01

Regulatory Information: Classification Name: laser for disruption of adipocyte cells for aesthetic use; Classification: II; Product Code: PKT; Regulation Number: 21 CFR 878.5400 ; Review Panel: General & Plastic Surgery ;

Indication for Use:

1060nm laser body slimming machine 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, flank, back, and thighs.

న్. Device Description

The 1060nm laser body slimming machine is an ultra-thermal laser fat decomposition system that uses the latest technology for non-invasive body shaping. It uses 1060mm wavelength laser penetration to target adipose tissue, selectively heats fat cells, and reduces the number of fat cells in the area through blood and lymph metabolism to achieve shaping the purpose of body contouring. It is a new generation of safe and effective way to lose weight.

Detailed description of cooling function

The handle head integrates a temperature sensor and skin contact sensor dual mechanism. The principle of the temperature sensor is based on the characteristic that the resistance of the NTC thermistor changes with the change of temperature, thereby achieving the measurement and monitoring of temperature. The principle of skin contact sensor is depending on whether it is in contact with the skin or not, the change signal of the resistance between the probes can be monitored to monitor the contact status with the skin.

The model of the 1060nm laser body slimming machine: RZ-01.

The subject device includes the following components:

Components	Function Description
1.Handle	The handle is the working component of the treatment. According to the
treatment parameters set by the user, the treatment is carried out.
2.Screen	The device is equipped with a 15-inch true color touch screen.

		Table 1 Main Components of Subject Device
--	--	-------------------------------------------	--	--

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| 3.Emergency

switch	stop	Press this button to disconnect the control system,and power supply in an emergency situation,turn right and eject the button to return to normal.
4.Casters	Push the equipment horizontally to the designated position.
5.Button switch	Start device work or stop device work.

Identification of Predicate Device 6.

510(k) Number: K201731 Product Name: Diode Laser Body Sculpture System Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.

Non-Clinical Test Conclusion 7.
Non-clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
A IEC 60601-1:2005+A1:2012+AMD2:2020,Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
IEC 60601-2-22: 2019, Medical electrical equipment -Part 2-22: Particular requirements for the safety and essential performance of surgical,cosmetic and diagnostic laser equipment;
IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests;
IEC 60825-1:2014 Safety of Laser products-Part 1:Equipment classification andrequirements;
IEC60601-1-6:2010+A1:2013+A2:2020 , Medical electrical equipment - Part 1-6: General basic safety and essential performance – Collateral standard: Usability; requirements for
IEC 62366-1:2015.Medical devices - Application of usability engineering to medical devices;
IEC62304:2015, Medical device software Software life cycle processes; >
ISO 14971:2019, Medical devices Application of risk management to medical devices; >
ISO 10993-1:2020, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process;
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity;
ISO 10993-10:2021, Biological Evaluation of Medical Device, Part 10-Test for irritation and skin sensitization;
ISO 10993-23:2021, Biological evaluation of medical devices - Part 23: Tests for irritation:
Clinical Test Conclusion 8.

No clinical study is included in this submission.

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Pulse

mode

width/Output

CW

| ITEM | Subject Device | Predicate Device
(K 201731) | Discussion |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | PKT - Laser for disruption of
adipocyte cells for aesthetic
use | PKT - Laser for disruption
of adipocyte cells for
aesthetic use | SE |
| Regulation
Number | 21 CFR 878.5400 | 21 CFR 878.5400 | SE |
| Regulatory Class | Class II | Class II | SE |
| Clinical Use | Prescription use | Prescription use | SE |
| Indication for Use | 1060nm laser body slimming
machine 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. | The Diode Laser Body
Sculpture Systems 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. | SE |
| User Interface | Touch screen | Touch screen | SE |
| Firmware
Controlled | Yes | Yes | SE |
| Laser type | Diode laser | Diode laser | SE |
| Output
Wavelength | 1060nm | 1060nm±20 nm | SE |
| Lipolysis
method/Treatment
regimen | Heat-assisted | Heat-assisted | SE |
| Spot size | $4 * 8 cm^2$ | $4 * 6 cm^2 /4 * 8$
cm² on each of the | SE |
| Irradiance | $0.7W/cm^2 - 1.5W/cm^2$ | $0.8 \sim 1.6W/cm^2$ | SE |
| Attachment to patient | Belt | Belt | SE |
| Peak power/Radiant power | $50W$ (per applicator) for $4 * 8 cm^2$ | $35W$ (per applicator) for $4 * 6 cm^2$
$50W$ (per applicator) for $4 * 8 cm^2$ | SE |
| Cooling | Contact cooling | Contact cooling | SE |

Table 2 General Comparison

CW

Applicator heads

body treatment)

(up to four applicators per

SE

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Table 4 Safety Comparison

Item	Subject Device	Predicate Device
Electrical Safety	Comply with IEC 60601-1, IEC 60601-2-22	Comply with IEC 60601-1, IEC 60601-2-22
	EMC	Comply with IEC 60601-1-2
Laser Safety	Comply with IEC 60825-1	Comply with IEC 60825-1

Analysis1:

Although the power density values of subject device and predicate device are different, the power density values of subject device is within the range of the value of predicate device, and the safety and effectiveness of predicate device are verified, so the difference has no impact on the safety and effectiveness of subject device.

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate device.