Dermatological Diode Laser Systems

K210663 · Beijing HuaCheng Taike Technology Co., Ltd. · GEX · Apr 26, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210663
• Device Name: Dermatological Diode Laser Systems
• Applicant: Beijing HuaCheng Taike Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dermatological Diode Laser Systems(Model:CM01D/CM02D) 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 (CM01D/CM02D) utilize semiconductor diode technology to emit 808nm infrared laser radiation. Device consists of main unit, laser handpiece, and foot-switch. Laser energy is absorbed by melanin in hair follicles to achieve permanent hair reduction. Operated by clinicians in professional settings. User selects parameters via color touch LCD screen; laser emission activated by foot-switch. Output parameters include pulse width (15-400ms), energy density (0.3-100J/cm2), and frequency (1-10Hz) depending on model. Device provides targeted thermal energy to hair follicles; clinical benefit is long-term, stable reduction in hair regrowth. Safety ensured through compliance with electrical, electromagnetic, and laser safety standards.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), laser safety (IEC 60601-2-22, IEC 60825-1), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Diode laser (808nm); Class IV. Materials: 6061 Aluminum, Quartz (handpiece tip), ABS (housing). Energy source: AC 110V/60Hz. Models: CM01D (15.6" screen, 10x30mm spot) and CM02D (4.3" screen, 9x12mm spot). Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993.

Indications for Use

Indicated for hair removal and permanent hair reduction on 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 Hair Removal Device (K180353)

Reference Devices

• SILKPRO Laser Hair Removal System (K142845)

Submission Summary (Full Text)

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April 26, 2021

Beijing HuaCheng Taike Technology Co., Ltd. % Hui Liu Official Correspondent Beijing Believe Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K210663

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: February 27, 2021 Received: March 5, 2021

Dear Hui Liu:

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 and Part 809); 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 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 ([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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K210663

Device Name

Dermatological Diode Laser Systems

Indications for Use (Describe)

The Dermatological Diode Laser Systems(Model: CM01D/CM02D) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-V), including tanned 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)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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.

The assigned 510(k) Number: K210663

- 1. Date of Preparation
04/15/2021

- 2. Sponsor
#### Beijing HuaCheng Taike Technology Co., Ltd.

5102P,Floor1,Building5,No.17Yunshannanlu Road, Tongzhou Industrial Development Zone,Tongzhou district, 101113 Beijing, P.R. China Contact Person: Li Yi Position: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- Submission Correspondent 3.
Contact Person:

Mr. Ray Wang(Primary)

Tel: [phone]

Fax: [phone]

Email: [e-mail]

Ms. Hui Liu (Secondary) Tel: [phone] Fax: [phone] Email: [e-mail]

#### Beijing Believe Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401

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- 4. Identification of Proposed Device
Trade Name: Dermatological Diode Laser Systems Common Name: Powered Laser Surgical Instrument Model(s): CM01D/CM02D

Regulatory Information: Classification Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Classification: II; Product Code: GEX; Regulation Number: 21 CFR 878.4810;

Indication For Use:

The Dermatological Diode Laser Systems(Model:CM01D/CM02D) 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 Description న్.

The Dermatological Diode Laser Systems utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via s laser handpiece. The emission laser is activated by a foot-switch.

There are 2 models included,CM01D,CM02D, the two models have same mechanism of action, principle and specification, only difference is the configuration. The detailed difference shown as following:

| | CM01D | CM02D |
|----------------------|---------------------------------------|-----------------------------------------|
| Display | 15.6" color touch LCD screen | 4.3" color touch LCD screen |
| Treatment laser spot | 10×30 mm | 9× 12 mm |
| Pulse width | 15-400 ms (continuously adjustable ) | 35-400 ms ( continuously adjustable ) |
| Energy density | 05-100J/ cm2 (continuously adjustable | 03-30J/ cm2 ( continuously adjustable ) |
| Pulse frequency | 1-10Hz | 1-3Hz |
| Size | 63*52*46cm | 49*44*139cm |
| Weight | 75Kg | 3Kg |

#### Table 1 The Difference of Models

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- 6. Identification of Predicate Device
Predicate Device 510(k) Number: K180353 Product Name: Diode Laser Hair Removal Device Manufacturer: Zhengzhou PZ Laser Slim Technology Co., Ltd

Reference Device 510(k) Number: K142845 Product Name: SILKPRO Laser Hair Removal System Manufacturer: Wuhan Lotuxs Technology Company, Ltd.

- 7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was to be as safe, as effective, and perform as well as the legally marketed predicate devices.. The test results demonstrated that the proposed device complies with the following standards:

- > ES60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: General AAMI Requirements for Safety And Essential Performance
- > IEC 60601-2-22:2007 + A1:2012, Medical Electrical Equipment - Part 2: Particular requirements for 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 - Electromagnetic Compatibility
- > ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
- > ISO 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1
- > Software Validation & Verification Test

According to "guidance for the content of premarket submissions for software contained in medical devices" issued by FDA, software verification and validation activities were carried out. Verification and validation activities include the verification and validation of product function, product performance and product interface. All verification and validation activities can meet the specified requirements, and the product software is safe and effective.

- Clinical Test Conclusion 8.
No clinical study is included in this submission.

- Comparison with Predicate and Reference Devices 9.

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# Table 2 General Comparison

| ITEM | Proposed Device | Predicate Device (K180353) | Reference Device (K142845) | Remark |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | GEX | GEX | OHT | Same |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Class | 2 | 2 | 2 | Same |
| Indication For Use | The Dermatological Diode Laser Systems(Model:CM01D/CM02D) 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 hair removal device 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. | SILKPRO is an over-thecounter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. SILKPRO is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. | Same |
| Configuration | Main Unit | Main Unit | / | Same |
| | Handpiece | Handpiece | / | Same |
| | Foot Control | Foot Control | / | Same |
| Principle of<br>Operation | Diode Laser | Diode Laser | Diode Laser | Same |

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| ITEM | Proposed Device | Predicate Device (K180353) | Reference Device (K142845) | Remark |
|-------------------------|--------------------------------------------------|----------------------------|----------------------------|------------|
| Laser Type | Diode Laser | Diode Laser | Diode Laser | Same |
| Laser<br>Classification | Class IV | Class IV | Class IV | Same |
| Laser<br>wavelength | 808 nm | 808 nm | 810 nm | Same |
| Spot Size | CM01D:10 × 30 mm<br>CM02D:9× 12 mm | $1.44 cm^2$ | 9mm×9mm (0.81cm²) | Analysis |
| Fluence | CM01D:5-100J/ cm2<br>CM02D:03-30J/ cm2 | 1-100J/ cm2 | 5-25J/cm2 | Analysis 2 |
| Frequency | CM01D: 1 - 10 Hz;<br>CM02D: 1 - 3 Hz | 1-20Hz | / | Analysis5 |
| Pulse Duration | CM01D:15-400 ms<br>CM02D:35-400 ms | 10-400ms | / | Similar |
| Power Supply | AC 110V/60Hz | AC 110V/60Hz | AC100~240V, 50/60Hz | Same |
| Dimension | CM01D:65cmX65cmX123cm<br>CM02D:253mm*210mm*193mm | 560mm x 380mm x1 180mm | / | Analysis |
| Weight | CM01D:75KG<br>CM02D:3kg | 60kg | | Analysis |

#### Table 3 Performance Comparison

#### 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 safety and effectiveness.

#### Analysis 2

The proposed device is different in fluence from the predicate device, the difference is very slight. Fluence of the proposed device is within the range of the predicate and reference devices.And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test ,IEC60825-1 test, the safety and performance of the product can be ensured. So the proposed device is determined to be as safe, as effective, and performs as well as the legally marketed predicate devices.

#### Analysis 3/ 4

The proposed device is different in dimension and weight from the predicate device. 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 safety and effectiveness.

#### Analysis 5

The proposed device is different in Frequency from the predicate device, the frequency is the number of times light is emitted in a second. The Frequency of the proposed device is within the range of the

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predicate device.And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test ,IEC60825-1 test, the safety and performance of the product can be ensured. therefore, this difference will not affect the safety and effectiveness.

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| Item | Proposed Device | Predicate Device (K180353) | Reference Device (K142845) | Remark |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------|----------------------------------------------|-----------|
| 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 | Comply with IEC 60601-1, IEC 60601-2-22 | Same |
| EMC | Comply with IEC 60601-1-2 | 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 | Comply with IEC 60601-2-22, IEC 60825 | Same |
| Patient Direct/Indirect Contact Materials and Biocompatibility | | | | |
| Patient<br>Direct/Indirect<br>Contact Materials | Tip of Handle (6061 Aluminium &Quartz )<br>Device Housing (Acrylonitrile Butadiene<br>Styrene) | Sapphire in handpiece | Stainless steel and Sapphire in<br>handpiece | Analysis6 |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Comply with ISO 10993-1 | Same |
| Sensitization | No evidence of sensitization | No evidence of sensitization | | |
| Irritation | No evidence of irritation | No evidence of irritation | | |

#### Table 4 Safety Comparison

#### Analysis 6:

The proposed device is different in Patient Indirect Contact Materials from the predicate device, to confirm that the components and materials contained in the finished device as identified above are not adverse to human tissue, the biocompatibility testing was performed in accordance with ISO 10993-1: 2009 and guidance document entitled Blue Book Memo, G95-1, Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing.The results for the biocompatibility testing showed that there are no negative impacts from the materials that are used in the proposed device, therefore, this difference will not affect the safety and effectiveness.

#### 10. Conclusion

Based on the comparison and analysis above, the proposed device is determined to be as safe, as effective, and performs as well as the legally marketed predicate devices.