SLIMUS

K192970 · Hironic Co., Ltd. · PKT · Dec 1, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K192970
• Device Name: SLIMUS
• Applicant: Hironic Co., Ltd.
• Product Code: PKT · General, Plastic Surgery
• Decision Date: Dec 1, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SLIMUS 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. Vibrator installed inside each hand-piece and operable only in non-laser output condition is intended for relief from minor muscle aches and pains.

Device Story

Diode laser system (1060 nm) for non-invasive lipolysis; heat-assisted fat reduction; integrated vibrator in handpieces for relief of minor muscle aches/pains. Handpieces fixed to patient via belt. Operable in laser mode (lipolysis) or non-laser mode (vibration). Used in clinical settings; operated by healthcare professionals. Laser energy targets adipose tissue; thermal effect disrupts adipocytes. Vibrator provides mechanical stimulation. Output allows clinicians to treat fat bulges; patient benefits from non-invasive body contouring and muscle pain relief.

Clinical Evidence

No clinical performance testing was performed. Substantial equivalence is supported by non-clinical bench testing, including electrical safety, electromagnetic compatibility, laser safety, biocompatibility, and software validation.

Technological Characteristics

Diode laser system; 1060 ± 20 nm wavelength; CW pulse width; 4x6 cm2 spot size; 1.4 W/cm2 power density. Belt-based applicator attachment. Biocompatibility per ISO 10993-1, -5, -10. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22. Software lifecycle per IEC 62304.

Indications for Use

Indicated for non-invasive lipolysis of abdomen, flanks, back, and thighs in individuals with BMI ≤ 30. Also indicated for relief of minor muscle aches and pains via integrated vibrator.

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 (K171111)

Submission Summary (Full Text)

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December 1, 2020

HIRONIC Co., Ltd % Sanghwa Myung Regulatory Affairs Consultant E&M D-1474, 230, Simin-daero, Dongan-gu Anyang-Si. 14067 Kr

Re: K192970

Trade/Device Name: Slimus Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use 878.5650 Regulatory Class: Class II Product Code: PKT, ISA Dated: March 12, 2020 Received: March 17, 2020

Dear Sanghwa Myung:

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 (OS) 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.

Purva Pandya Acting 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 SLIMUS

Indications for Use (Describe)

The SLIMUS 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.

Vibrator installed inside each hand-piece and operable only in non-laser output condition is intended for relief from minor muscle aches and pains.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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Image /page/3/Picture/2 description: The image shows the logo for Hironic. The logo consists of a red square with a white arrow pointing to the right, followed by the word "HIRONIC" in black, sans-serif font. The logo is simple and modern, and the red and black colors give it a bold and professional look.

# 510(k) Summary

## This summary of 510(k) Safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

#### 1. Submitter Information

| Applicant | Hironic Co., Ltd. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 19F, 767, Sinsu-Ro, Suji-Gu, Yongin-Si, Gyeonggi-do,<br>16827, Republic of Korea |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Contact Person | Sang Hwa, Myung |
| Contact Information | D-1474, 230, Simin-daero, Dongan-gu, Anyang-si,<br>Gyeonggi-do, 14067, Republic of Korea<br>m. [phone], e. [e-mail], f. 031-388-<br>9263 |

#### Date 510(k) summary prepared: October 26th, 2020

### 2. Device Name and Product Code

| Device Trade Name | SLIMUS |
|---------------------|-----------------------------------------------------------|
| Common Name | Low Intensity Laser System |
| Classification Name | Laser for disruption of adipocyte cells for aesthetic use |
| Product Code | PKT |
| Regulation Number | 21 CFR 878.5400 - Low Intensity Laser System |
| Regulatory Class | II - Low Intensity Laser System |
| Review Panel | General & Plastic Surgery (ODE) |

#### 3. Legally marketed device(s) to which equivalence is claimed

| Predicate Device | Sculpsure (K171111) |
|------------------|---------------------|
|------------------|---------------------|

#### 4. Device

The SLIMUS device incorporates a laser system that emits a 1060 nm wavelength using a diode laser. Laser radiation is emitted from the laser main unit to the device's handpieces through the handpiece fibers. The device is used to noninvasively reduce the size of the waist of overweight patients with a Body Mass Index (BMI) of less than 30 (kg/m²). A vibrator function is installed inside of each hand-piece and operable only in non-laser output mode. The device's handpieces are fixed to a belt which then combined provide mechanical vibration to the patient in order provide relief from minor muscle aches and pains.

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5. Indication for Use

The SLIMUS is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs. Vibrator installed inside each hand-piece and operable only in non-laser output condition is intended for relief from minor muscle aches and pains ..

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Image /page/5/Picture/2 description: The image shows the logo for Hironic. The logo consists of a red square with a white arrow pointing to the right, followed by the word "HIRONIC" in black, block letters. The logo is simple and modern, and the colors are eye-catching.

## 6. Summary of the Technological Characteristics of the Device Compared to the Predicate

| | Proposed SLIMUS | Predicate |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | SculpSure™ |
| 510(k) Number | K192970 | K171111 |
| Manufacturer | Hironic Co., Ltd. | Cynosure, Inc. |
| Lipolysis<br>Method | Heat-assisted | Heat-assisted |
| Device Type | Diode Laser | Diode Laser |
| Indication for<br>use | The SLIMUS is intended for non-<br>invasive lipolysis of the abdomen,<br>flanks, back, and thighs in individuals<br>with a Body Mass Index (BMI) of 30 or<br>less. The device is intended to affect<br>the appearance of visible fat bulges<br>in the abdomen, flanks, back, and<br>thighs. Vibrator installed inside each<br>hand-piece and operable only in non-<br>laser output condition is intended for<br>relief from minor muscle aches and<br>pains. | The Cynosure SculpSure™ is intended<br>for non-invasive lipolysis of the<br>abdomen, flanks, back, and thighs in<br>individuals with a Body Mass Index<br>(BMI) of 30 or less. The device is<br>intended to affect the appearance of<br>visible fat bulges in the abdomen,<br>flanks, back, and thighs. |
| Wavelength | 1060 ± 20 nm<br>(infrared) | 1060 ± 20 nm<br>(infrared) |
| Spot Size | 4 x 6 cm2 on each of the<br>Applicator heads | 4 x 6 cm2 on each of the<br>Applicator heads |
| Pulse Width<br>(laser On time) | CW | CW |
| Power Density | Up to 1.4 W/cm2 | Up to 1.4 W/cm2 |
| Attachment to<br>patient | Belt | Belt |
| Rated Input | AC 220-230 V, 4 kVA | AC 200-240 V, 20 A |

### 7. Non-clinical tests submitted - 807.92(b)(1)

- -. Basic safety and essential performance of the SLIMUS is evaluated in accordance with IEC 60601-1:2012.
- -. Effect to the device by electromagnetic disturbances is evaluated in accordance with the FDA-recognized consensus standard, IEC 60601-1-2:2014.
- -. Safety of laser products is evaluated in accordance with IEC 60825-1:2014.
- -. General Requirements for Basic Safety and Essential Performance Collateral Standard: Usability is evaluated in accordance with the FDA-recognized consensus standard, IEC 60601-1-6:2013.
- -. Particular Requirements for Basic Safety and Essential Performance of Low Intensity Laser System are evaluated in accordance with IEC 60601-2-22:2012.
- -. Risk management is recorded in the reference of ISO 14971:2007.
- -. Software life cycle processes are evaluated according to the FDA-recognized consensus standard, IEC 62304:2006.
- -. Application of usability engineering to medical devices is evaluated in accordance with IEC 62366:2007.
- -. Biocompatibility of SLIMUS is documented in the reference of ISO 10993-1:2009, ISO 10993-5:2009, and 10993-10:2010.

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## 8. No Clinical performance testing was performed.

## 9. Discussion of non-clinical testing.

The non-clinical data for the SLIMUS device, including bench testing, electrical medical device safety, electromagnetic field compatibility, laser safety, biocompatibility, hardware, and software documentation together support that the device can perform as intended.

## 10. Conclusions

The SLIMUS device shares the same intended use and similar technological characteristics with the predicate device. These do not raise new types of questions regarding safety and efficacy for the SLIMUS when compared to the predicate. Based on its technical characteristics, indications for use, and performance data, the SLIMUS device is considered to be substantially equivalent to the predicate device.