Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)

K251339 · Zhengzhou PZ Laser Slim Technology Co., Ltd. · GEX · Jul 25, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K251339
• Device Name: Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
• Applicant: Zhengzhou PZ Laser Slim Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 25, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medical Diode Laser Hair Removal Device (PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) 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

Device is a powered laser surgical instrument for hair removal; utilizes 808nm diode laser radiation. Principle of operation: selective photothermolysis; laser energy absorbed by melanin in hair follicles to achieve permanent hair reduction. Features integrated cooling technology to protect skin during treatment. Operated by clinicians in professional settings. Output is controlled laser pulses; energy density and pulse duration vary by model and treatment head. Healthcare providers use device to perform hair removal procedures; patient benefits from long-term, stable reduction in hair regrowth.

Clinical Evidence

Bench testing only. No clinical study included.

Technological Characteristics

Diode laser (808nm); Class IV laser. Energy source: AC 100-240V. Cooling system integrated. Materials: biocompatible (ISO 10993-5, -10, -23 compliant). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1. Multiple models with varying spot sizes (0.28-2.88 cm²), pulse durations (3-108ms), and fluence (2-95 J/cm²).

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 Therapy Machine (K161692)

Reference Devices

• The Modified Alma Lasers Soprano XL Family of Multi-Application and Multi-Technology Platforms [SopranoXL, SopranoXLi and SopranoICE] (K140009)
• Dermatological Diode Laser Systems (K210663)
• Diode Laser Hair Removal System L808 (K141973)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 25, 2025

Zhengzhou PZ Laser Slim Technology Co., Ltd.
Xiaojie Shi
RA
Room 201, 2nd Floor, Building 2, No.52 Hongsong Road
High-tech Development Zone, 450001
China

Re: K251339
Trade/Device Name: Medical Diode Laser Hair Removal Device (PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
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: April 21, 2025
Received: April 30, 2025

Dear Xiaojie Shi:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251339 - Xiaojie Shi
Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K251339 - Xiaojie Shi
Page 3

Sincerely,

YAN FU -S
Digitally signed by YAN FU -S
Date: 2025.07.25 12:10:49
-04'00"

for Tanisha Hithe
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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K251399 | |
| Device Name Medical Diode Laser Hair Removal Device (PZ-606VIPZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) | |
| Indications for Use (Describe) The Medical Diode Laser Hair Removal Device (PZ-606VIPZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) 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) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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The assigned 510(k) Number: K251399

# 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 21 CFR 807.92.

1. Date of preparation: 07/24/2025

2. Sponsor Identification:

**Zhengzhou PZ Laser Slim Technology Co., Ltd.**

Room 201, 2nd Floor, Building 2, No. 52 Hongsong Road, High-tech Development Zone, 450001, Zhengzhou City, Henan Province, P. R. China.

Contact Person: Xiaojie Shi

Position: RA

Tel: [phone]

Fax: [phone]

Email: [e-mail]

3. Designated Submission Correspondent

**Zhengzhou PZ Laser Slim Technology Co., Ltd.**

Room 201, 2nd Floor, Building 2, No. 52 Hongsong Road, High-tech Development Zone, 450001, Zhengzhou City, Henan Province, P. R .China.

Contact Person: Xiaojie Shi

Tel: [phone]

Fax: [phone]

Email: [e-mail]

4. Identification of Proposed Device

Trade Name: Medical Diode Laser Hair Removal Device

Models: PZ-606VI、PZ-BDT68-01、PZ-BDT68-02、PZ-BDT68-03、PZ-BDT68-04

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Common Name: Powered Laser Surgical Instrument

Regulatory Information

Classification Name: Powered Laser Surgical Instrument

Classification: II

Product Code: GEX

Regulation Number: 21 CFR 878.4810

Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology.

Review Panel: General& Plastic Surgery

Intended Use:

The Medical Diode Laser Hair Removal Device (PZ-606VI、PZ-BDT68-01、PZ-BDT68-02、PZ-BDT68-03、PZ-BDT68-04) 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.

5. Device Description:

The proposed device, Medical Diode Laser Hair Removal Device (PZ-606VI、PZ-BDT68-01、PZ-BDT68-02、PZ-BDT68-03、PZ-BDT68-04), is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

The device incorporates a diode laser that emits invisible infrared laser radiation centered on a wavelength of 808 nm. According to the selective light absorption theory, the laser can be preferentially absorbed by the melanin in the hair follicle, thus achieving the purpose of permanent hair removal. 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. Hair growth must remain stable for a certain amount of time and must exceed the entire growth cycle of the hair follicle. Permanent hair removal does not mean that all hair in the treated area is completely lost. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin.

2 / 8

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There are 5 models included, PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03 and PZ-BDT68-04, the five models have the same intended use, mechanism of action and principle, only the minimum values of energy density and pulse duration are different. The detailed difference shown as following:

Table 1 The difference of Models

| Model | Wavelength | Laser emitter | Pulse width (Pulse duration) (±10%) | Energy density (±20%) |
| --- | --- | --- | --- | --- |
| PZ-606VI | 808nm±10nm (Handle 1) | 1000W 12*12 laser treatment head | 3-108ms | (2-50) J/cm2 |
| | | 1000W Φ6mm treatment head | 4-44ms | (3-30) J/cm2 |
| | 808nm±10nm (Handle 2) | 2000W 12*12 laser treatment head | 3-80ms | (3-95) J/cm2 |
| | | 2000W 12*24 laser treatment head | 3-80ms | (2-55) J/cm2 |
| | | 2000W Φ6mm treatment head | 3-22ms | (3-30) J/cm2 |
| PZ-BDT6 8-01 | 808nm±10nm (Handle 1) | 1000W 12*12 laser treatment head | 6-108ms | (5-50) J/cm2 |
| | | 1000W Φ6mm treatment head | 7-44ms | (5-30) J/cm2 |
| | 808nm±10nm (Handle 2) | 2000W 12*12 laser treatment head | 4-80ms | (5-95) J/cm2 |
| | | 2000W 12*24 laser treatment head | 8-80ms | (5-55) J/cm2 |
| | | 2000W Φ6mm treatment head | 5-22ms | (5-30) J/cm2 |
| PZ-BDT6 8-02 | 808nm±10nm (Handle 1) | 1000W 12*12 laser treatment head | 12-108ms | (10-50) J/cm2 |
| | | 1000W Φ6mm treatment head | 15-44ms | (10-30) J/cm2 |
| | 808nm±10nm (Handle 2) | 2000W 12*12 laser treatment head | 9-80ms | (10-95) J/cm2 |
| | | 2000W 12*24 laser treatment head | 15-80ms | (10-55) J/cm2 |
| | | 2000W Φ6mm treatment head | 8-22ms | (10-30) J/cm2 |
| PZ-BDT6 8-03 | 808nm±10nm (Handle 1) | 1000W 12*12 laser treatment head | 3-108ms | (2-50) J/cm2 |
| | | 1000W Φ6mm treatment head | 7-44ms | (5-30) J/cm2 |

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| | | head | | |
| --- | --- | --- | --- | --- |
| | 808nm±10nm (Handle 2) | 2000W 12*12 laser treatment head | 3-80ms | (3-95) J/cm² |
| | | 2000W 12*24 laser treatment head | 3-80ms | (2-55) J/cm² |
| | | 2000W Φ6mm treatment head | 5-22ms | (5-30) J/cm² |
| PZ-BDT6 8-04 | 808nm±10nm (Handle 1) | 1000W 12*12 laser treatment head | 3-108ms | (2-50) J/cm² |
| | | 1000W Φ6mm treatment head | 15-44ms | (10-30) J/cm² |
| | 808nm±10nm (Handle 2) | 2000W 12*12 laser treatment head | 3-80ms | (3-95) J/cm² |
| | | 2000W 12*24 laser treatment head | 3-80ms | (2-55) J/cm² |
| | | 2000W Φ6mm treatment head | 8-22ms | (10-30) J/cm² |

6. Identification of Predicate Device and reference devices

Predicate device:

510(k) Number: K161692

Product Name: Diode Laser Therapy Machine

Manufacturer: Beijing ADSS Development Co., Ltd

Reference device1:

510(k) Number: K140009

Product Name: The Modified Alma Lasers Soprano XL™ Family of Multi-Application and

Multi-Technology Platforms [SopranoXL, SopranoXLi and SopranoICE]

Manufacturer: Alma Lasers Ltd

Reference device2:

510(k) Number: K210663

Product Name: Dermatological Diode Laser Systems

Manufacturer: Beijing HuaCheng Taike Technology Co., Ltd.

Reference device3:

510(k) Number: K141973

Product Name: Diode Laser Hair Removal System L808

Manufacturer: Beijing Anchorfree 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 Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

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IEC 60601-1:2005+A1:2012+A2:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;

IEC 60601-1-2:2014+A1:2020, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic - Requirements and tests;

IEC 60601-2-22:2019, Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements

ISO 10993-5:2009, Biological Evaluation of Medical Devices, Part 5-Tests for in Vitro cytotoxicity.

ISO 10993-10:2021, Biological Evaluation of Medical Devices, Part 10-Tests for skin sensitization

ISO 10993-23:2021, Biological Evaluation of Medical Devices-Part 23: Tests for irritation. Performance Testing for Spot Size Accuracy and Energy Output Accuracy.

## 8. Clinical Test Conclusion

No clinical study is included in this submission.

## 9. Substantially Equivalent (SE) Comparison

Table 2 General Comparison

| Item | Proposed Device | Predicate Device | Remark |
| --- | --- | --- | --- |
| Product Code | GEX | GEX | Same |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Intended Use | The Medical 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. | The Diode Laser Therapy Machine 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 | Main Unit | Same |
| | Handle | Handpiece | Same |
| | Handle Button | Foot Control | Difference 1 |

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| Principle of Operation | Diode Laser | Diode Laser | Same |
| --- | --- | --- | --- |
| Laser Type | Diode Laser | Diode Laser | Same |
| Laser Classification | Class IV | Class IV | Same |
| Laser Wavelength | 808nm | 808nm | Same |
| Spot Size | 1.44cm² | 1.44cm² | Same |
| | 2.88cm² | | Difference 2 |
| | 0.28cm² | | |
| Energy Density (Fluence) | (1)1000W 12*12 treatment head: (2-50) J/cm² (2)1000W Φ6mm treatment head: (3-30)J/cm² (3)2000W 12*12 treatment head: (3-95)J/cm² (4)2000W 12*24 treatment head: (2-55)J/cm² (5)2000W Φ6mm treatment head: (3-30)J/cm² | 2-120J/cm² | Difference 3 |
| Frequency | (1)1-10Hz (2)1-3Hz | 1-10Hz | Same |
| Pulse Duration | (1)1000W 12*12 laser treatment head: 3-108ms (2)1000W Φ6mm treatment head: 4-44ms (3)2000W 12*12 laser treatment head: 3-80ms (4)2000W 12*24 laser treatment head: 3-80ms (5)2000W Φ6mm treatment head: 3-22ms | 9-143ms | Difference 4 |
| Power Supply | AC100-240V 50/60Hz | AC 110V/50Hz-60Hz | Difference 5 |
| Dimension | 550mm*550mm*1700mm | 56*46*112 cm | Difference 6 |
| | | 42*63*54cm | |
| | | 56*46*110cm | |
| | | 59*59*146 cm | |
| Weight | 68kg | 49kg | Difference 7 |
| | | 30kg | |
| | | 45kg | |
| | | 45kg | |

Analysis:
Difference1:

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The predicate device emits laser through Foot Control; The proposed device emits laser through Handle Button. By complying with IEC 60601-1, the performance of the proposed device is determined to be accepted, therefore, this difference will not affect the effectiveness and safety.

## Difference 2:

The spot size of the subject device (1.44cm², 2.88 cm², and 0.28 cm²) differs from predicate device (1.44cm²).

For the small spot size (0.28 cm²), which is the same as the spot size of the 6mm round tapered light guide tip in K140009, the round area is calculated to be 0.28 cm², it is the same as that of the subject device.

The large spot size (2.88 cm²) is similar to the spot size (3 cm²) of CM01D in K210663, and the spot size of the proposed device is slightly smaller than 3 cm².

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

## Difference 3:

The proposed device has different Fluence from the predicate device. The fluence of the proposed device is within the range of the predicate device, which can justify that the difference in the parameter of fluence will not raise new safety issues of the proposed 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, the safety and performance of the product can be ensured. And we think this minor difference will not affect the effectiveness and safety.

## Difference 4:

The proposed device has different pulse duration from the predicate device (K161692). The pulse duration of the predicate device is 9-143ms, and the pulse duration of the subject device is 3-108ms. The pulse duration between the proposed device and the predicate device only with minor difference. The K141973 (pulse duration 2.9-348ms) as a scientifically valid justification that extending the pulse duration of the proposed device to 3-108ms is as safe and effective as the predicate device, and the K141973 has the same indication for use with predicate device will not affect the effectiveness and safety. And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test, IEC60825-1 test and performance test, the safety and performance of the product can be ensured.

## Difference 5:

The power supply for the proposed device is different from the predicate device. However, electrical safety and EMC test has been conducted on the proposed device and the test result show that the device can work normally under this power supply. Therefore, this difference will not affect safety and effectiveness of the proposed device.

## Difference 6:

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The proposed device is different in dimension 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 of dimension have no effect the effectiveness and safety.

# Difference 7:

The proposed device is different in 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 of weight have no effect the effectiveness and safety.

Table 3 Safety Comparison

| Item | Proposed Device | Predicate Device | Remark |
| --- | --- | --- | --- |
| Patient Contact Materials and Biocompatibility | | | |
| 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 |
| 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 |

# 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.