Diode Laser Body Sculpture System

K201731 · Shanghai Apolo Medical Technology Co., Ltd. · PKT · Sep 10, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K201731
• Device Name: Diode Laser Body Sculpture System
• Applicant: Shanghai Apolo Medical Technology Co., Ltd.
• Product Code: PKT · General, Plastic Surgery
• Decision Date: Sep 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

HS-851 Diode Laser Body Sculpture System uses 1060nm infrared laser energy for non-invasive hyperthermic lipolysis; targets adipose tissue to reduce fat cell count and contour body. System comprises main unit, control unit with software/UI, and treatment applicators. Operated by clinician in clinical setting; applicators secured to patient via belt. Device utilizes contact cooling during treatment. Output is heat-assisted disruption of adipocytes; intended to improve appearance of fat bulges. Benefits include non-invasive body contouring without surgery.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety, electromagnetic compatibility (IEC 60601-1, IEC 60601-1-2), laser safety (IEC 60825-1, IEC 60601-2-22), and biocompatibility (cytotoxicity, skin irritation, skin sensitization per ISO 10993-1).

Technological Characteristics

1060nm (±20nm) infrared diode laser; CW pulse width; contact cooling; power density 0.8-1.6W/cm²; peak power 35W-50W per applicator; belt-based attachment. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22. Biocompatibility per ISO 10993-1.

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)
• Powersculp laser lipolysis system (K191068)

Submission Summary (Full Text)

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September 10, 2020

Shanghai Apolo Medical Technology Co., Ltd. Mr. Felix Li RA Supervisor Room 301-310, Building 11, No.388, Yindu Road, Xuhui District Shanghai, Shanghai 200231 China

Re: K201731

Trade/Device Name: Diode Laser Body Sculpture System Regulation Number: 21 CFR 878.5400 Regulation Name: Low Level Laser System For Aesthetic Use Regulatory Class: Class II Product Code: PKT Dated: June 18, 2020 Received: June 24, 2020

Dear Felix 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.

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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 (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,

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) K201731

Device Name Diode Laser Body Sculpture Systems

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# K201731-510(k) summary

#### l Submitter

Shanghai Apolo Medical Technology Co., Ltd. Room 301-310, Building 11, No.388, Yindu Road, Xuhui District, 200231, Shanghai China Establishment Registration Number: 3007120647

Contact person: Felix Li Position: Regulatory Affairs Phone: [phone] Fax: [phone] E-mail: [e-mail]

Date of preparation: Sep 9th, 2020

#### 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 |
| 510(k) Number: | K191068 |
| Trade name: | Powersculp laser lipolysis system |
| Common name: | Low Level Laser System for Aesthetic Use |
| Classification: | Class II |
| Product Code: | PKT |
| Manufacturer | Wuhan Lotuxs Technology Co., Ltd. |

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### IV Device description

The HS-851 Diode Laser Body Sculpture Systems is a 1060nm Diode Hyperthermic Laser Lipolysis system and utilizes the latest technology for non-invasive body contouring. It applies a 1060nm wavelength laser to target the adipose tissue to reduce stubborn fat in areas such as flank, abdomen, back and thighs.

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.

The proposed device consists of the main unit, control unit with dedicated software and user interface, and the treatment applicators.

#### V Indication for use

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.

| Item | Proposed device | Primary<br>predicate<br>device<br>(K182741) | Secondary<br>predicate<br>device<br>(K191068) | Discussion |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product<br>Code | PKT | PKT | PKT | Identical |
| Regulation<br>No. | 21 CFR 878.5400 | 21 CFR 878.5400 | 21 CFR 878.5400 | Identical |
| Class | Class II | Class II | Class II | Identical |
| Indication<br>for use | This product is<br>intended for<br>non-invasive<br>lipolysis of the<br>abdomen, flanks,<br>back, and thighs<br>in individuals with<br>a Body Mass<br>Index (BMI) of 30<br>or less. The | The Cynosure<br>SculpSure™ is<br>intended for<br>non-invasive<br>lipolysis of the<br>abdomen,<br>flanks, back, and<br>thighs in<br>individuals with<br>a Body Mass | The Powersculp<br>laser lipolysis<br>system is<br>intended for<br>non-invasive<br>lipolysis of the<br>flank and<br>abdomen to<br>achieve<br>disruption of | Equivalent |
| | device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs. | Index (BMI) of 30 or less. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a BMI of 49 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area. When using the petite mask for non-invasive lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area. | adipocyte celles intended for non-invasive aesthetic use to achieve a desired aesthetic effect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less. | |
| Laser type | Diode laser | Diode laser | Diode laser | Identical |
| Wavelength | 1060nm±20 nm (infrared) | 1060nm±20 nm (infrared) | 1060nm±20 nm (infrared) | Identical |
| Lipolysis method | Heat-assisted | Heat-assisted | Heat-assisted | Identical |
| Spot size | $4 * 6 cm^2/4 * 8 cm^2$ on each of the Applicator heads (up to four | $4 * 6 cm^2$ on each of the Applicator heads (up to four | $4 * 8 cm^2$ (A single applicator of four applicators) | Equivalent |
| | applicators per<br>body treatment) | applicators per<br>body treatment)<br>14.28 cm² (for<br>standard<br>submental<br>mask)<br>10.49 cm² (for<br>petite submental<br>mask) | | |
| Pulse width | CW | CW | CW | Identical |
| Power<br>density | 0.8 ~ 1.6W/cm² | Up to 1.4 W/ cm²<br>(body)<br>Up to 3.06 W/<br>cm²<br>(submental) | Up to 0.7-1.7W/<br>cm² | Equivalent |
| Attachment<br>to patient | Belt | Belt | Belt | Identical |
| Voltage | AC110-240V,<br>50/60Hz, 20-4A | AC200-240V,<br>50/60Hz, 20A | AC100-240V,<br>50/60Hz, 15A | Equivalent |
| Peak<br>power | 35W (per<br>applicator) for 4 *<br>6 cm²<br>50W (per<br>applicator) for 4 *<br>8 cm² | 30W (per<br>applicator) | 50W (per<br>applicator) | Equivalent |
| Cooling | Contact cooling | Contact cooling | Contact cooling | Identical |

#### VI Comparison of technological characteristics with the predicate devices

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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

- 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical ● IEC electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment -Part 1-2: General ●

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requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests

- IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and requirements
- IEC 60601-2-22:2007(third edition)+A1:2012 for use in conjunction with IEC ● 60601-1:2005 (third edition)+A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

## Biocompatibility Evaluation:

Per FDA's Biocompatibility Guidance issued on June 16, 2016 and with regard to Table A.1 Evaluation Tests for consideration in ISO, "Use of international Standard ISO 10993-1, Biological evaluation of medical - 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; ●
- Skin Sensitization .; ●

## VIII Clinical Testing

It is not applicable.

fonclusion substantially equivalent to the predicate device.