DUO

K161565 · Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd · ONF · Sep 1, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K161565
• Device Name: DUO
• Applicant: Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Sep 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DUO (Model: IPL-HH380-IT) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. The DUO is also intended for permanent reduction in unwanted hair. 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 regimen.

Device Story

DUO (Model: IPL-HH380-IT) is a home-use, over-the-counter Intense Pulsed Light (IPL) device for hair removal. Device uses a Quartz Xenon Lamp to emit light (480-1200nm) to heat hair roots; operation is AC-powered. User activates pulses via finger switch. Device includes skin proximity and skin pigmentation sensors to ensure safety; device will not trigger if not in full contact with skin or if skin tone is too dark/tanned. Output intensity is adjustable across 5 levels. Device life is limited to 300,000 cycles, after which it ceases operation. Intended for adult use to achieve long-term stable reduction in hair regrowth.

Clinical Evidence

Bench testing only. Safety and performance evaluated via electrical safety (IEC 60601-1, IEC 60601-2-57), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10). Biocompatibility testing (cytotoxicity, sensitization, irritation) passed criteria.

Technological Characteristics

IPL-based hair removal; Quartz Xenon Lamp; 480-1200nm spectrum; 5 intensity levels; 3 cm² spot size; max fluence 5 J/cm². Housing/contacts: PC 2805. AC powered (100-240V). Sensors: skin proximity, skin pigmentation. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57.

Indications for Use

Indicated for removal of unwanted body and/or facial hair in adults and permanent reduction in unwanted hair.

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

• Lumena FH Hair Removal System (K140631)
• Sensi Light Mini (K140527)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol. The logo is black and white.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 1, 2016

Stetic Medical Aesthetics Development (Shenzhen) Co., Ltd. % Iris Fung Official Correspondent SGS-CSTC Standards Technical Services Co., Ltd. 198 Kezhu Road. Scientech Park Guangzhou Guangzhou. CN

Re: K161565 Trade/Device Name: Duo 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: ONF, OHT Dated: May 30, 2016 Received: June 6, 2016

Dear Iris Fung:

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. 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 statutes and regulations administered by other Federal agencies. You must comply

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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 devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation , please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Christopher J. Ronk -S

- For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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## Indications for Use

510(k) Number (if known) K161565

Device Name DUO, Model: IPL-HH380-IT

#### Indications for Use (Describe)

The DUQ (Model: IPL-HH380-IT) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. The DUO is also intended for permanent reduction in unwanted hair. 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 regimen.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="padding-right: 5px;"> <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span style="padding-left: 5px;"> <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

---

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

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## 510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

## 1. Submitter's Information

## Sponsor

- � Company Name: STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. , LTD
- � Address: 10-11th Floor, Bensi Building, New High-Tech-Park, Ganli Village, Buji District, Shenzhen, China
- Phone: [phone] �
- � Fax: [phone]
- � Contact Person (including title): Yejuan
- E-mail: [e-mail] �

## Application Correspondent:

- � SGS-CSTC Standards Technical Services Co., Ltd.
- � Address: 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & Technology Development District, Guangzhou, Guangdong, CHINA
- � Contact Person: Ms. Iris Fung
- Tel: [phone] �
- Email: [e-mail] �

#### Subject Device Information 2.

- DUO, Model: IPL-HH380-IT � Trade Name:
- DUO Common Name: �
- Powered Light Based Non-Laser Surgical Instrument With Classification name: �
- Thermal Effect
- General & Plastic Surgery Review Panel: �
- ONF � Product Code:
- 2 Regulation Class: �
- 878.4810 Regulation Number: �

Page 13 of 59 Report by STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD

STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD Sponsor: Subject Device: DUO, Model: IPL-HH380-IT

510(k) submission report (V1.0), Chapter 6 510(k) Summary File No.:

#### 3. Predicate Device Information

| Sponsor | Shaser, Inc. | EL Global Trade Ltd. |
|-------------------|-------------------------------|----------------------|
| Device Name | Lumena FH Hair Removal System | Sensi Light Mini |
| 510(k) Number | K140631 | K140527 |
| Product Code | ONF | OHT |
| Regulation Number | 878.4810 | 878.4810 |
| Regulation Class | 2 | 2 |

#### 4. Device Description

DUO, Model: IPL-HH380-IT,a small over-the-counter,is a home-use device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve

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any cutting or pulling, reducing hair growth with minimal pain.A personal Light-Based Hair Removal System.Emission activation is by finger switch.Device includes a treatment window head,a facial adaptor and battery charger/AC cord.lt is used AC Powered(100-240 V AC; 50/60 Hz).The weight of the device is 280g, and the size is 130 x 70 x 30 mm (H x W x D).The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.The device contains a Quartz Xenon Lamp,a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the DUO is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the DUO will not trigger a pulse. The spot size (treatment area) in the DUO device is 3 cm². When the lamp had been subjected to operation of 300000 cycles, then the indicator light on the device is flashing at the frequency of 2Hz , it means that the device life has reached the end, the device stops working.

#### 5. Intended Use / Indications for Use

The DUO (Model: IPL-HH380-IT) is an over the Counter device intended for the removal of unwanted body and/or facial hair in adults. The DUO is also intended for permanent reduction in unwanted hair. 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 regimen.

#### 6. Design

DUO, Model: IPL-HH380-IT,a small over-the-counter,is a home-use device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.A personal Light-Based Hair Removal System.Emission activation is by finger switch. Device includes a treatment window head,a facial adaptor

Page 14 of 59 Report by STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. LTD

STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD Sponsor: Subject Device: DUO, Model: IPL-HH380-IT

#### File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary

and battery charger/AC cord.lt is used AC Powered(100-240 V AC; 50/60 Hz).The weight of the device is 280g, and the size is 130 x 70 x 30 mm (H x W x D).The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device contains a Quartz Xenon Lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the DUO is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the DUO will not trigger a pulse. The spot size (treatment area) in the DUO device is 3 cm². When the lamp had been subjected to operation of 300000 cycles, then the indicator light on the device is flashing at the frequency of 2Hz , it means that the device life has reached the end, the device stops working.

#### 7. Materials

There are two user directly contracting components in the subject device as the following list.

| Component of<br>Device Requiring<br>Biocompatibility | Material of<br>Component | Body Contact<br>Category<br>(ISO 10993-1) | Contact Duration<br>(ISO 10993-1) |
|------------------------------------------------------|--------------------------|-------------------------------------------|-----------------------------------|
| Housing | PC 2805 | Surface-contacting<br>device: skin | Maximum 30<br>minutes(< 24hours) |
| Output contacts | PC 2805 | Surface-contacting<br>device: skin | Maximum 30<br>minutes(< 24hours) |

The Nature of body contact is surface, skin contact. And the contact duration is less than 24 hours. According to Table 1 - Initial evaluation tests for consideration in ISO 10993-1, the applicable biological effect is:

- ತಿ Cytotoxicity
- ூ Sensitization
- ு Irritation or intracutaneous reactivity
- 1. Cytotoxicity Test

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(1) Test Method

MTT Method in ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity, Edition 3.0, 2009;

(2) Passing Criteria

As our subject device is only for limited skin contacting, we set the criteria for NON-TOXIC to be "no more than Grade 2" according to United States Pharmacopoeia.

(3) Test Result

The Cytotoxicity test result showed the device had no toxicity to L929 cell. The test result is passed the criteria.

2. Skin Sensitization Test

Page 15 of 59 Report by STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. . LTD

STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD Sponsor: Subject Device: DUO, Model: IPL-HH380-IT

File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary

(1) Test Method

Guinea Pig Maximization Test in ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, Edition 3.0, 2010;

(2) Passing Criteria

As our subject device is for limited skin contacting, we set the criteria to be "Grade 0" according to United States Pharmacopoeia.

(3) Test Result

The Skin Sensitization test result for device is Grade 0. The test result is passed the criteria.

3. Skin Irritation Test

(1) Test Method

0.9% Sodium Chlorid Injection and Sesame oil Extract in ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, Edition 3.0, 2010;

(2) Passing Criteria

As our subject device is for limited skin contacting, we set the criteria to be "0-0.4 for Irritation Index" according to United States Pharmacopoeia.

(3) Test Result

The Skin Irritation test results for Component is 0 for Irritation Index. The test result is passed the criteria.

- 8. Physical characteristics

| Basic Unit Characteristics | |
|----------------------------------------|------------------------------------------------------------------------------------|
| Compliance* with 21 CFR 898 | No |
| Main Unit Weight | 280g |
| Main Unit Dimension | 130*70*30mm |
| Housing Materials of main unit | PC2805 |
| Indicator | Indicates power information, LED of mode information, intensity level information. |
| Time Range (minutes) | 30 mins |
| Environment for operation | Temperature: 10°C~35°C<br>Humidity: 30~75% |
| Storage and Transport Conditions | Temperature: -15°C~55°C<br>Humidity: 10~90% |
| Compliance with Voluntary<br>Standards | Yes,Comply with IEC 60601-1, IEC 60601-1-2,<br>IEC 60601-2-57 |
| Patient leakage current | Comply with IEC 60601-1 |
| Power Source | Supplied by external adapter |
| Software/Firmware/Microprocessor | Yes |

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STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD Sponsor: Subject Device: DUO, Model: IPL-HH380-IT

| Control? | |
|-----------------------------------------|-----------------------------------------------------------------------------------|
| Specification | |
| Output Intensity Level | 5 |
| Output energy without facial<br>adaptor | Level 1:>7.7J<br>Level 2:>8.5J<br>Level 3:>9.4J<br>Level 4:>10.5J<br>Level 5:>12J |
| Output energy with facial adaptor | Level 1:>4.0J<br>Level 2:>4.7J<br>Level 3:>5.4J<br>Level 4:>5.9J<br>Level 5:>6.7J |
| Emitted Light Spectrum | 480nm~1200nm Max |
| Pulse Duration: | [<20ms] |
| Single pulse irradiation time | 500ms |
| Emitted Energy Flue | 5 [Joules/cm²] |
| Treatment Area (regular window) | 3 [cm²] |
| Max pulses in lamp | up to 300,000 |
| Power Supply | 100-240 VAC, 50/60Hz |
| Technology | IPL |

#### File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary

#### 10. Test Summary

DUO, Model: IPL-HH380-IT has been evaluated the safety and performance by lab bench testing as following:

- ு Electrical safety test according to IEC 60601-1 and IEC 60601-2-57 standards
- ரி Electromagnetic compatibility test according to IEC 60601-1-2 standard
- ூ Software verification and validation test according to the requirements of the FDA "Guidance for PreMarket Submissions and for Software Contained in Medical Devices"

#### 11. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, and intended use of DUO, model: IPL-HH380-IT is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Report by STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD Page 17 of 59

STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD Sponsor: Subject Device: DUO, Model: IPL-HH380-IT

| Elements of<br>Comparison | Subject Device | Predicate Device | Remark |
|---------------------------|------------------------------|---------------------------------------------------|--------|
| Device Name and<br>Model | DUO, Model: IPL-<br>HH380-IT | Lumena FH Hair Removal<br>System Sensi Light Mini | -- |
| 510(k) Number | Applying | K140631 K140527 | -- |

510(k) submission report (V1.0), Chapter 6 510(k) Summary File No.:

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| Manufacturer | STETIC MEDICAL<br>AESTHETICS<br>DEVELOPMENT<br>(SHENZHEN) CO.,LTD | Shaser, Inc. | EL Global Trade Ltd. | -- |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Intended Use | The DUO (Model: IPL-<br>HH380-IT) is an over the<br>Counter device intended<br>for the removal of<br>unwanted body and/or<br>facial hair in adults. The<br>DUO is also intended for<br>permanent reduction in<br>unwanted hair.<br>Permanent hair<br>reduction is defined as<br>the long-term stable<br>reduction in the number<br>of hairs regrowing when<br>measured at 6. 9. and<br>12 months after the<br>completion of a<br>treatment regimen. | Lumena FH is an over the<br>Counter device intended<br>to provide<br>phototherapeutic light to<br>the body. It is also<br>intended for removal of<br>unwanted hair by using a<br>selective photothermal<br>treatment. It is also<br>indicated for the removal<br>of unwanted body and/or<br>fhcial hair in adults<br>with Fitzpatrick skin types<br>I - IV. The Lumena PH is<br>also intended for<br>permanent reduction in<br>unwanted hair. Permanent<br>hair reduction is defined<br>as the long-term stable<br>reduction in the number of<br>hairs regrowing when<br>measured at 6,9 and 12<br>months after the<br>completion of a treatment<br>regimen. | The sensi Light Mini is<br>an over the counter<br>devices intended for<br>the removal of<br>unwanted hair. The<br>sensi Light Mini is also<br>intended for<br>permanent reduction in<br>hair regrowth,<br>defined as a long-term,<br>stable reduction in the<br>number of hairs<br>regrowing when<br>measured at 6, 9 and<br>12 months after the<br>completion of a<br>treatment regimen. | SE |
| Source Energy | Supplied by external<br>adapter | AC Mains | an external power<br>supply | SE<br>Note 1 |
| 'Use'<br>Classification | OTC | OTC | OTC | SE |
| Device<br>Classification | Class II | Class II | Class II | SE |
| Device Type | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | SE |
| Wavelength (nm) | 480nm~1200nm | 400nm~1200nm | 475nm~1200nm | SE<br>Note 2 |

Report by STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD Page 18 of 59

Sponsor: STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD Subject Device: DUO, Model: IPL-HH380-IT

File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary

| Elements of<br>Comparison | Subject Device | Predicate Device | | Remark |
|------------------------------|---------------------------------|---------------------------------|---------------------------------|--------------|
| Max. Fluence<br>(J/cm2) | 5 [Joules/cm²] | 6 [Joules/cm²] | 5 [Joules/cm²] | SE<br>Note 2 |
| Spot Size (cm2) | 3 [cm²] | 2[cm²] | 3 [cm²] | SE<br>Note 2 |
| User Interface | LED Indicator lights | LED Indicator lights | LED Indicator lights | SE |
| Pulsing Control | Finger switch | Finger switch | Finger switch | SE |
| Control<br>Mechanism | Microprocessor-based<br>Control | Microprocessor-based<br>Control | Microprocessor-based<br>Control | SE |
| Number of Output<br>Channels | One channel | One channel | One channel | SE |

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| Output Intensity<br>Level | 5 levels | 5 levels | -- | SE |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------|
| Software/Firmwar<br>e/Microprocessor<br>Control? | Yes | Yes | Yes | SE |
| 60601Compliance<br>with Voluntary<br>Standards | Yes<br>Comply with IEC 60601-<br>1 and IEC 60601-1-2,<br>IEC60601-2-57 | Yes<br>Comply with IEC 60601-1<br>and IEC 60601-1-2,<br>IEC60601-2-57, | Yes<br>Comply with IEC<br>60601-1 and IEC<br>60601-1-2,IEC60601-<br>2-57,IEC60601-1-11 | SE |
| Compliance* with<br>21 CFR 898 | No | No | No | SE |
| Weight | 280g | 1Kg | -- | SE<br>Note 1 |
| Dimensions | 130*70*30mm | 22*16*78cm (H*W*D) | -- | SE<br>Note 1 |
| Standards | | | | |
| Biocompatibility | All user directly<br>contacting materials are<br>compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly contacting<br>materials are compliance<br>with ISO10993-5 and<br>ISO10993-10<br>requirements. | All user directly<br>contacting materials<br>are compliance with<br>ISO10993-5 and<br>ISO10993-10<br>requirements. | SE |
| Electrical Safety | Comply with | Comply with | Comply with | SE |

Report by STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD Page 19 of 59

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STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD Sponsor: Subject Device: DUO, Model: IPL-HH380-IT

#### File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary

| Elements of<br>Comparison | Subject Device | Predicate Device | Remark | |
|---------------------------|---------------------------------|-----------------------------------|-----------------------------------|--|
| | IEC60601-1 and<br>IEC60601-2-57 | IEC 60601-1 and<br>IEC 60601-2-57 | IEC 60601-1 and<br>IEC 60601-2-57 | |

#### Comparison in Detail(s):

#### Note 1:

"Power Source(s)","Weight", "Dimensions" is belong to basic characteristics. Although it is a little different from the predicate devices, it will not affect the main function and the intended use of the device. They all also comply with IEC 60601-1 requirements. So the differences will not raise any safety or effectiveness issue.

#### Note 2:

Although the "Wavelength (nm)", "Max. Fluence (J/cm2)", and "Spot Size (cm2)" of subject device are a little different from the predicate devices, they all comply with IEC 60601-2-57 requirement.So the differences of function specification will not raise any safety or effectiveness issue.

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