Diode Laser Hair Removal System

K191970 · Beijing Sano Laser S&T Development Co.,Ltd · GEX · Apr 6, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K191970
• Device Name: Diode Laser Hair Removal System
• Applicant: Beijing Sano Laser S&T Development Co.,Ltd
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 6, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Diode Laser Hair Removal 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.

Device Story

Diode Laser Hair Removal System; surgical laser device for hair removal/permanent hair reduction. Operates via diode laser (808 nm) delivered through handpiece to treatment area. User interface (touch screen/LED screen) allows parameter setting; foot switch controls laser output. Emergency stop and key switch provided for safety. Used in clinical settings by trained operators. Laser energy targets hair follicles to achieve long-term reduction. Benefits patient through permanent hair reduction across all skin types.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Diode laser (808 nm); Class IV laser. Handpiece tip materials: Sapphire and stainless steel. Dimensions vary by model (P-808, P-808L, P-808S, P-808W). Compliance: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2. Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization).

Indications for Use

Indicated for hair removal and permanent hair reduction in patients of all Fitzpatrick skin types (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 Machine (K161692)

Submission Summary (Full Text)

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April 6, 2020

Beijing Sano Laser S&T Development Co., Ltd % Huifang Zhao Consultant Microkn Business Consulting (Shanghai)Co., Ltd Room 1319, Block A, No 3699, Gonghexin Road, Jingan District Shanghai, 200435 CN

Re: K191970

Trade/Device Name: Diode Laser Hair Removal System 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 5, 2020 Received: March 5, 2020

Dear Huifang Zhao:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jessica Mavadia-Shukla, Ph.D. 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) K191970

Device Name Diode Laser Hair Removal System

#### Indications for Use (Describe)

The Diode Laser Hair Removal 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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

#### Date Prepared: 4/5/2020

## 1. Contact Information

## 1.1. Applicant

| Applicant Name: | Beijing Sano Laser S&T Development Co., Ltd. |
|-----------------|----------------------------------------------------------------------------------|
| Address: | Room 7-201, No.1, Caida 3rd Street, Nancai Town, Shunyi District, Beijing, China |
| Contact Person: | Hongbo Zhang |
| Title: | Manager |
| Telephone: | [phone] |
| E-mail: | [e-mail] |

## 1.2. Consultant

| Company: | Microkn Business Consulting (Shanghai) Co., Ltd. |
|-----------------|----------------------------------------------------------------------------------|
| Address: | Room 1319, Block A, No 3699, Gonghexin Road, Jingan<br>District, Shanghai, China |
| Contact Person: | Huifang Zhao |
| Telephone: | [phone] |
| Email: | [e-mail] |

## 2. Device information

| Trade Name: | Diode Laser Hair Removal System |
|-----------------|-----------------------------------|
| Common Name: | Powered Laser Surgical Instrument |
| Model(s): | P-808, P-808L, P-808S, P-808W |
| Classification: | II |
| Product Code: | GEX |
| Regulation: | 21 CFR 878.4810 |

## 3. Legally Marketed Primary Predicate Device

| Product name: | Diode Laser Therapy Machine |
|----------------|-----------------------------------|
| 510(k) Number: | K161692 |
| Product Code: | GEX |
| Manufacture: | Beijing ADSS Development Co., Ltd |

## 4. Device Description

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The proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended for hair removal, permanent hair reduction on all Fitzpatrick skin types.

There are 4 models included, P-808, P-808L, P-808S and P-808W, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration. The detailed difference shown in Table 1.

| Model | P-808 | P-808L | P-808S | P-808W |
|---------------------------|-----------|-----------|-----------|-----------|
| Size (cm) | 46x36x105 | 45x37x110 | 47x36x113 | 47x32x112 |
| Size of LED screen (inch) | 10 | 10 | 12 | 10 |

Table 1 the Difference of Models

The main components of proposed device are shown in Table 2.

| Table 2 Main Components of Proposed Device | | |
|--------------------------------------------|--|--|
| | | |

| Components | Function Description | Applied Model(s) |
|-----------------------|------------------------------------------------------------------------|------------------|
| Handpiece | Deliver the laser to area to be treated | All Models |
| Touch screen | The user interface and for controlling of the system | All Models |
| Emergency stop switch | Stop the system in case of emergency situation | All Models |
| Key switch | Start the system | All Models |
| LED screen | Display the working status of the system, set the treatment parameters | All Models |
| Foot switch | control the laser output | All Models |

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#### 5. Indications for Use

The Diode Laser Hair Removal 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.

## 6. Substantially Equivalent (SE) Comparison

The Diode Laser Hair Removal System has been carefully compared to legally marketed devices with respect to intended use, configuration, principle of operation (Table 3), and performance specifications (Table 4).

| Item | Proposed Device | Predicate Device | Remark |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Product Code | GEX | GEX | SE |
| Regulation<br>Number | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Intended Use | The Diode Laser Hair<br>Removal System is<br>intended for hair<br>removal, permanent hair<br>reduction on all skin<br>types (Fitzpatrick skin<br>type I-VI), including<br>tanned skin. Permanent<br>hair reduction is defined<br>as the long-term, stable<br>reduction in the number<br>of hairs regrowing when<br>measured at 6, 9, and 12<br>months after the<br>completion of a<br>treatment regime. | The Diode Laser Therapy<br>Machine is intended for hair<br>removal, permanent hair<br>reduction on all skin types<br>(Fitzpatrick skin type I-VI),<br>including tanned skin.<br>Permanent hair reduction is<br>defined as the long-term,<br>stable reduction in the number<br>of hairs regrowing when<br>measured at 6, 9, and 12<br>months after the completion of<br>a treatment regime. | SE, with<br>difference in<br>wording,<br>while the<br>actual<br>indications<br>are the<br>same. |

Table 3 General Comparison

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| Configuration | | | |
|------------------------------|--------------|--------------|----|
| | Main Unit | Main Unit | SE |
| | Handpiece | Handpiece | SE |
| | Foot Control | Foot Control | SE |
| Principle<br>of<br>Operation | Diode Laser | Diode Laser | SE |

#### Table 4 Performance Comparison

| ltem | Proposed Device | Predicate Device | Remark |
|----------------------|-----------------|-------------------|--------------|
| Laser Type | Diode Laser | Diode Laser | SE |
| Laser Classification | Class IV | Class IV | SE |
| Laser Wavelength | 808 nm | 808 nm | SE |
| Spot Size | 1.44 cm² | 1.44 cm² | SE |
| Fluence | 10-120 J/cm2 | 2-120 J/cm2 | Discussion 1 |
| Frequency | 0.5-10 Hz | 1-10 Hz | SE |
| Power Supply AC | 110V/60Hz | 110 V/50 Hz-60 Hz | SE |

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Discussion 1

The proposed device is different from the predicate device in fluence value, but the proposed device's fluence value range is included in the predicate's fluence value. Therefore, this difference will not affect the substantially equivalency.

Safety comparison has been done to validate the EMC, biocompatibility specification and safety of the device (Table 5).

| Item | Proposed Device | Predicate Device | Remark |
|------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|--------|
| Patient Contact Materials and Biocompatibility | | | |
| Patient Contact<br>Materials | Sapphire in handpiece and<br>handpiece tip (Stainless Steel) | Sapphire in handpiece and<br>handpiece tip (Stainless Steel) | SE |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | SE |
| Skin<br>sensitization | No evidence of sensitization | No evidence of sensitization | SE |
| Irritation | No evidence of irritation | No evidence of irritation | SE |
| EMC, Electrical and Laser Safety | | | |
| Electrical safety | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Laser safety | Comply with IEC 60601-2-22,<br>IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | SE |

#### Table 5 Safety Comparison

## 7. Non-Clinical Testing

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 60601-2-22:2012, Medical Electrical Equipment Part 2-22: Particular .

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

- IEC 60825-1: 2007, 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 AMENDMENT 1: Performance Testing for Spot Size Accuracy and Energy Output Accuracy.

## 8. Clinical Test Conclusion

No clinical study is included in this submission.

## 9. Conclusion

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