Dermatological diode laser system

K212478 · Beijing Stelle Laser Technology Co., Ltd. · GEX · Jan 14, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K212478
• Device Name: Dermatological diode laser system
• Applicant: Beijing Stelle Laser Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 14, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dermatological diode laser 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

Dermatological diode laser system uses semiconductor diode to emit 808nm infrared laser; energy absorbed by melanin in hair follicles; thermal destruction of germinal cells; surrounding tissue spared; debris removed by phagocytic cells. Device comprises main unit, handpiece, and foot-switch. Operated by clinicians in professional settings (salons/spas). Laser parameters (fluence, pulse duration, frequency) adjustable via interface. Benefits include long-term, stable hair reduction. Four models (ADPL2, ALD1, DPL4, LD1) share core technology, differing only in shell design.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-2-22), EMC (IEC 60601-1-2), laser safety (IEC 60825-1), biocompatibility (ISO 10993-5, ISO 10993-10), and performance testing for spot size and energy output accuracy.

Technological Characteristics

Semiconductor diode laser; 808nm wavelength; Class IV laser. Energy fluence 1-120J/cm²; pulse duration 10-400ms; frequency 1-10Hz. Materials: ABS plastic, aluminum, quartz. Standards: AAMI ES60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5/10. Connectivity: None specified. Power: 100/110V or 230-260V, 50/60Hz.

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 System (K162659)

Submission Summary (Full Text)

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January 14, 2022

Beijing Stelle Laser Technology Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K212478

Trade/Device Name: Dermatological diode laser 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: December 1, 2021 Received: December 9, 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) K212478

Device Name Dermatological diode laser system

### Indications for Use (Describe)

The Dermatological diode laser 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 style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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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: K212478

- Date of Preparation 1.
01/13/2022

- Sponsor 2.
## Beijing Stelle Laser Technology Co., Ltd.

Rm.502-1, Tower B, Building1, Yard 26, Zhongguancun Medical Device Park, Yongwang West Rd., Biomedical Industry Base, Daxing Dist., 102600 Beijing, P.R. China Contact Person: Zhao Changcheng Position: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

#### 3. Submission Correspondent

Contact Person:

Mr. Ray Wang Tel: [phone] Fax: [phone] Email: [e-mail]

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

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

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#### Identification of Proposed Device 4.

Trade Name: Dermatological diode laser system Common Name: Powered Laser Surgical Instrument Model(s): ADPL2/ALD1/DPL4/LD1

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

Indication for Use:

The Dermatological diode laser 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.

#### న్. Device Description

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.

The laser light targets on melanin and treat selectively in a precise way. Melanin could absorb the energy from the laser, which would result in temperature rapid increase, to destroy germinal cell and does not damage epidermis and the surrounding normal tissue. After laser exposure, the debris of these cells is removed from the body by phagocytic cells.

The four models of different products produced by our company are consistent in Wavelength , Energy Fluence, Pulse Duration, Energy deviation, Spot Size, Frequency and so on. It's just that the shell is slightly different.

| | ADPL2 | ALD1 | DPL4 | LD1 |
|------------------|----------------------------|----------------------------|----------------------------|----------------------------|
| Wavelength | 808nm±10nm | 808nm±10nm | 808nm±10nm | 808nm±10nm |
| Energy Fluence | 1-120J/cm²<br>(Adjustable) | 1-120J/cm²<br>(Adjustable) | 1-120J/cm²<br>(Adjustable) | 1-120J/cm²<br>(Adjustable) |
| Pulse Duration | 10-400 ms | 10-400 ms | 10-400 ms | 10-400 ms |
| Energy deviation | ±20% | ±20% | ±20% | ±20% |
| Spot Size | 12*12mm | 12*12mm | 12*12mm | 12*12mm |
| Frequency | 1-10Hz | 1-10Hz | 1-10Hz | 1-10Hz |

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Pictures of four models of shell:

Image /page/5/Picture/2 description: The image shows a medical device that is white and blue. The device has a screen on the top and a handle on the side. The device is on wheels, which makes it easy to move around. There is a red button and a keyhole on the front of the device.

ADPL2

Image /page/5/Picture/4 description: This image shows a white and gold laser hair removal machine. The machine has a screen at the top, a red button, and a gold accent. The machine is on wheels, and there is a white cord attached to the side.

ALD1

Image /page/5/Picture/6 description: The image shows a white medical device on wheels. The device has a screen on top and a handle on the side. There is a red button on the front of the device. The device is used for medical treatments.

DPL4

Image /page/5/Picture/8 description: The image shows a white and gold laser hair removal machine. The machine has a screen at the top, a handle on the side, and wheels on the bottom. The machine is designed to be used in a professional setting, such as a salon or spa.

LD1

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- 6. Identification of Predicate Device
Predicate Device 510(k) Number: K162659 Product Name: Diode Laser Hair Removal System Manufacturer: Shandong Huamei Technology Co., Ltd.

#### Non-Clinical Test Conclusion 7.

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:

- > AAMI ES60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Safety and Essential Performance;
- > IEC 60601-2-22:2007, Medical Electrical Equipment - Part 2-22: Particular 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 60601-1-2:2007, 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 10993-10:2002/Amd. 1: 2006, 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.
- > Software Validation & Verification Test
- Clinical Test Conclusion 8.

No clinical study is included in this submission.

- 9. Substantially Equivalent (SE) Comparison

| ITEM | Proposed Device(K212478) | Predicate Device (K162659) | Remark |
|-------------------|--------------------------|----------------------------|--------|
| Product<br>Code | GEX | GEX | Same |
| Regulation<br>No. | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |

### Table 1 General Comparison

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| Class | 2 | 2 | Same |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Intended<br>Use | The Dermatological diode laser system is intended<br>for hair removal, permanent hair reduction on all<br>skin types (Fitzpatrick skin type I-VI), including<br>tanned skin.<br>Permanent hair reduction is defined as the long-<br>term, stable reduction in the number of hairs<br>regrowing when measured at 6, 9, and 12 months<br>after the completion of a treatment regime. | The Diode Laser System is intended for hair<br>removal, permanent hair reduction on all<br>skin types (Fitzpatrick skin type I-VI),<br>including tanned<br>skin.<br>Permanent hair reduction is defined as the<br>long-term, stable reduction in the number of<br>hairs regrowing when measured at 6, 9, and 12 months<br>after the completion of a<br>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 | Same |

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| ITEM | Proposed Device(K212478) | Predicate Device (K162659) | Remark |
|-------------------------|--------------------------------------|----------------------------|------------|
| Laser Type | Diode Laser | Diode Laser | Same |
| Laser<br>Classification | Class IV | Class IV | Same |
| Laser<br>wavelength | 808 nm | 808 nm | Same |
| Spot Size | 12×12mm | 14×14mm | Analysis 1 |
| Fluence | 120J/cm² | 1-120J/ cm2 | Same |
| Pulse Duration | 10-400ms | 5-400ms | Similar |
| Power Supply | 100/110V,50/60Hz or 230-260V,50/60Hz | AC 110V/60Hz | Analysis 2 |
| Dimension | 519mm×923mm×474mm | 450mm× 550mm×380mm | Analysis 3 |
| Weight | 42Kg | 52Kg | Analysis 4 |

## Table 2 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 substantially equivalency.

# Analysis 2

The proposed device is different in fluence from the predicate device, the difference is very slight. Frequency of proposed device is within the predicate device. And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test, IEC60825-1 test and performance test (Energy density and Spot Size), the safety and performance of the product can be ensured. So the proposed device is determined to be substantially equivalency with predicate device.

### 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 substantial equivalency.

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| Item | Proposed Device(K212478) | Predicate Device (K162659) | 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 | 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 Indirect<br>Contact<br>Materials | ABS plastic.<br>Metal aluminum.<br>Window Quartz | Sapphire in handpiece | Similar |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same |
| Sensitization | No evidence of sensitization | No evidence of sensitization | Same |
| Irritation | No evidence of irritation | No evidence of irritation | Same |

# Table 3 Safety Comparison

# 10. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.