Dermatological Diode Laser Systems

K202257 · Zhuolu Jontelaser Manufacturing Technology Co., Ltd. · GEX · Apr 23, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202257
• Device Name: Dermatological Diode Laser Systems
• Applicant: Zhuolu Jontelaser Manufacturing Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 23, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dermatological Diode Laser Systems is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Device Story

Dermatological Diode Laser Systems (T5 Pro/T8 Pro) are Class IV diode laser devices used for hair removal and permanent hair reduction. Operated by clinicians in hospital settings, the device delivers 808 nm laser energy to the skin via a handpiece. The system includes a touchscreen interface for control, a foot switch for laser activation, and safety features like an emergency switch and key switch. The laser energy targets hair follicles to achieve long-term reduction. The device is configured as either a trolley-mounted (T8 Pro) or desktop (T5 Pro) unit. Clinical benefit is derived from the stable reduction of hair regrowth over 6-12 months. The device does not involve remote processing or cloud connectivity.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including electrical safety, EMC, laser safety, and biocompatibility testing (cytotoxicity, irritation, and sensitization).

Technological Characteristics

Diode laser (808 nm) surgical instrument; Class IV laser. Patient-contacting materials include quartz (aluminum and SiO2). Dimensions vary by model (T5 Pro: 63x52x46cm; T8 Pro: 49x44x139cm). Power supply: AC 100-240V/50-60Hz. Standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for hair removal and permanent hair reduction in patients of all skin types (Fitzpatrick I-VI), including tanned skin.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Diode Laser Therapy System (K192569)

Submission Summary (Full Text)

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April 23, 2021

Zhuolu Jontelaser Manufacturing Technology Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd Rm. 912, Building #15, XiYueHui, No.5, YiHue North Rd., FangShan District BeiJing, BeiJing 102401 China

Re: K202257

Trade/Device Name: Dermatological Diode Laser Systems Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: March 23, 2021 Received: March 26, 2021

Dear Ray Wang:

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 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) K202257

Device Name Dermatological Diode Laser Systems

Indications for Use (Describe)

The Dermatological Diode Laser Systems is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------|
| <div><span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> |
| <div><span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# 510(k) Summary

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.

- 1. Date of Preparation
08/06/2020

- 2. Applicant Name and Address
Zhuolu Jontelaser Manufacturing Technology Co., Ltd. No. 31, Sanguanmiao Alley, Zhuolu Town, Zhuolu County, Zhangjiakou City, Hebei, China, 072750

- Contact Person Information 3. Karen Liu General Manager Tel: [phone] Fax: [phone] Email: [e-mail]
- 4. Submission Correspondent

Mr. Ray Wang Beijing Believe Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing City, China, 102401 Tel: [phone] Fax: [phone] Email: ray.wang(@believe-med.com

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- Identification of Proposed Device 5.
Trade Name: Dermatological Diode Laser Systems Common Name: Powered Laser Surgical Instrument Model(s): T5 Pro/T8 Pro

Classification Name: Powered Laser Surgical Instrument Classification: II; Product Code: GEX; Regulation Number: 21 CFR 878.4810; Review Panel: General& Plastic Surgery;

- Identification of Primary Predicate 6. 510(k) Number: K192569 Product Name: Diode Laser Therapy System Manufacturer: San He Lefis Electronics Co., Ltd.
#### Device Description 7.

The proposed device, Diode Laser Therapy System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

There are 2 models included, T5 Pro and T8 Pro, the two models have same intended use, mechanism of action, principle and specification, only difference is the configuration. The detailed difference shown as following:

| Model | T5 Pro | T8 Pro |
|--------|------------|-------------|
| Size | 63*52*46cm | 49*44*139cm |
| Weight | 48Kg | 57Kg |

Table 1 The Difference of Models

The main components of proposed device shown as following:

| Components | Function Description | Applied Model(s) |
|------------------|------------------------------------------------------|------------------|
| Handpiece | Deliver the laser to area to be treated | T5 Pro/T8 Pro |
| Touchscreen | The user interface and for controlling of the system | T5 Pro/T8 Pro |
| Emergency Switch | Stop the system in case of emergency situation | T5 Pro/T8 Pro |
| Key Switch | Start the system | T5 Pro/T8 Pro |
| Connector | Connection of the device with the handpiece | T5 Pro/T8 Pro |
| Indicator Lamp | Indicate current working state of the appliance | T5 Pro/T8 Pro |
| Foot Switch | Activate the laser emission | T5 Pro/T8 Pro |

Table 2 Main Components of Proposed Device

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- Indication For Use 8.
The Dermatological Diode Laser Systems is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

- 9. Substantially Equivalent (SE) Comparison

| ITEM | Proposed Device | Predicate Device | Remark |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | GEX | GEX | SAME |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | 2 | 2 | SAME |
| Where used | Hospital | Hospital | SAME |
| Intended Use | The Dermatological Diode Laser Systems is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. | The Diode Laser Therapy System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. | SAME |
| Configuration | Main Unit<br>Handpiece<br>Foot Control | Main Unit<br>Handpiece<br>Foot Control | SAME |
| Principle of<br>Operation | Diode Laser | Diode Laser | SAME |

# Table 3 General Comparison

| ITEM | Proposed Device | Predicate Device | Remark |
|----------------------|-----------------------|-------------------|------------|
| Laser Type | Diode Laser | Diode Laser | SAME |
| Laser Classification | Class IV | Class IV | SAME |
| Laser wavelength | 808 nm | 808 nm | SAME |
| Spot Size | 2.4 cm2 | 2.8 cm2 | Analysis 1 |
| Fluence | 2-40 J/cm2 | 2-40 J/cm2 | SAME |
| Frequency | 1-10 Hz | 1-10 Hz | SAME |
| Pulse Duration | 10-400 ms | 3-400 ms | Similar |
| Power Supply | AC 100-240V/50Hz-60Hz | AC 110V/50Hz-60Hz | SAME |

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| Dimension | 49*44*139cm | 51*60*100cm | Analysis 2 |
|-----------|-------------|-------------|------------|
| | 63*52*46cm | | |
| Weight | 57KG | 45kg | Analysis 3 |
| | 48KG | | |

### Table 5 Safety Comparison

| Item | Proposed Device | Predicate Device | Remark |
|------------------------------------------------|--------------------------------------------------------------|--------------------------------------------|------------|
| EMC, Electrical and Laser Safety | | | |
| Electrical Safety | Comply with IEC 60601-1, IEC<br>60601-2-22 | Comply with IEC 60601-1, IEC<br>60601-2-22 | SAME |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | SAME |
| Patient Contact Materials and Biocompatibility | | | |
| Patient Contact<br>Materials | Quartz in handpiece and handpiece tip<br>(aluminum and SiO2) | Stainless steel and Sapphire in handpiece | Analysis 4 |
| Cytotoxicity | No Cytotoxicity | Comply with ISO 10993-1 | SAME |
| Sensitization | No evidence of sensitization | | |
| Irritation | No evidence of irritation | | |

#### Analysis 1

The proposed device is different in Spot Size from the predicate, Spot size only affects the area of treatment, not affect the therapeutic effect. Therefore, this difference will not affect the substantially equivalency.

#### Analysis 2/3

The proposed device is different in dimension and weight from the proposed device is a trolley type, while the predicate device is a desktop type. By complying with IEC 60601-1, the mechanical performance of the proposed device is determined to be accepted, therefore, this difference will not affect the substantially equivalency.

#### Analysis 4

The proposed device is different in patient-contacting materials. But all patient-contacting materials used in proposed device has been evaluated as ISO 10993-1, as the results of evaluation, there is no biocompatibility concerns raised from the patient-contacting materials used in proposed device, so this different will not affect the substantially equivalency.

#### 10. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- > IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
- > IEC 60601-2-22:2007, Medical Electrical Equipment - Part 2-22: Particular Requirements For

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Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment;

- > IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements.
- > 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.
- > ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
- > ISO 10993-10:2010, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity
- > Software Validation & Verification Test
- 11. Clinical Testing

No clinical study is included in this submission.

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