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 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 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.

AI/ML Overview

The provided text describes a 510(k) submission for the DUO, Model: IPL-HH380-IT, an Intense Pulsed Light (IPL) device for hair removal. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone clinical study with detailed acceptance criteria and performance data for the DUO device itself.

Therefore, the requested information, particularly regarding specific acceptance criteria with reported device performance results for a clinical study on the DUO device, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, is largely not available in this document.

The document details safety and performance testing through lab bench testing for electrical safety, electromagnetic compatibility, and software verification, as well as biocompatibility tests on materials. These are internal validation tests, not clinical performance studies against specific hair reduction efficacy criteria.

Here's a breakdown of what can be extracted and what is missing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines "acceptance criteria" through compliance with various standards and by demonstrating substantial equivalence to predicate devices for its intended use. However, it does not present a table of specific clinical performance acceptance criteria (e.g., percentage of hair reduction) for the DUO device, nor does it report the DUO's clinical performance against such criteria.

The "Indications for Use" section defines permanent hair reduction 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." This is a definition of the intended outcome, not a quantified acceptance criterion for this specific device's performance.

The document largely focuses on safety and technical specification compliance.

Acceptance Criteria Category	Specific Acceptance Criteria (from document)	Reported DUO Device Performance / Compliance
Intended Use	The device is an over-the-counter device intended for the removal of unwanted body and/or facial hair in adults, and for permanent reduction in unwanted hair (defined as long-term stable reduction in hair number at 6, 9, and 12 months post-treatment).	The DUO's stated intended use matches this definition. The document asserts 'substantial equivalence' to predicate devices for this intended use, implying that the DUO is expected to achieve similar results, though no direct performance data is presented for the DUO against this criterion.
Electrical Safety	Compliance with IEC 60601-1 and IEC 60601-2-57 standards.	"Electrical safety test according to IEC 60601-1 and IEC 60601-2-57 standards" was performed. Results state "Comply with IEC60601-1 and IEC60601-2-57".
Electromagnetic Compatibility	Compliance with IEC 60601-1-2 standard.	"Electromagnetic compatibility test according to IEC 60601-1-2 standard" was performed. Result implicitly passes by inclusion in "Test Summary" and statement of "Comply with IEC 60601-1 and IEC 60601-1-2".
Software Verification & Validation	Compliance with FDA "Guidance for PreMarket Submissions and for Software Contained in Medical Devices" requirements.	"Software verification and validation test according to the requirements of the FDA 'Guidance for PreMarket Submissions and for Software Contained in Medical Devices'" was performed. Result implicitly passes by inclusion in "Test Summary" and statement that the device has Software/Firmware/Microprocessor Control.
Biocompatibility (Housing & Output Contacts)	Cytotoxicity: No more than Grade 2 according to United States Pharmacopoeia (for limited skin contacting). Skin Sensitization: Grade 0 according to United States Pharmacopoeia (for limited skin contacting). Skin Irritation: 0-0.4 for Irritation Index according to United States Pharmacopoeia (for limited skin contacting).	Cytotoxicity: "The Cytotoxicity test result showed the device had no toxicity to L929 cell. The test result is passed the criteria." Sensitization: "The Skin Sensitization test result for device is Grade 0. The test result is passed the criteria." Irritation: "The Skin Irritation test results for Component is 0 for Irritation Index. The test result is passed the criteria." (All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements.)
Physical Characteristics (e.g., Weight, Dimensions, Wavelength, Fluence, Spot Size)	Compliance with relevant standards (e.g., IEC 60601-1, IEC 60601-2-57). Differences from predicates should not raise new safety or effectiveness issues.	Specific values are provided in the "Physical characteristics" table and "Comparison to predicate device" table. The document claims "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."
Device Life (Lamp)	Lamp life up to 300,000 pulses, with an indicator light flashing at 2Hz when end of life is reached and device stops working.	Device description states: "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." This describes the feature, implying its performance meets the design.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not mentioned in terms of clinical performance. The only "test set" mentioned are for bench testing (electrical, EMC, software) and biocompatibility (e.g., L929 cells for cytotoxicity, Guinea Pig for sensitization/irritation).
Data Provenance: Not applicable for a clinical study as no such study is presented for the DUO's clinical efficacy. For the referenced predicate devices, data provenance is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as no clinical efficacy test set is described. The ground truth for the biocompatibility tests (e.g., cytotoxicity, sensitization, irritation) is based on standardized biological assay results, not expert consensus in a clinical setting.

4. Adjudication method for the test set:

Not applicable as no clinical efficacy test set or corresponding adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an IPL hair removal system, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

A "standalone" performance in terms of clinical efficacy of hair reduction for the DUO device is not explicitly described or quantified with data in this document. The document primarily focuses on demonstrating that the DUO device meets safety and technical specifications and is substantially equivalent to predicate devices, which are themselves "standalone" (non-human-in-the-loop) devices designed for direct user application.

7. The type of ground truth used:

For Biocompatibility: Standardized biological tests (e.g., L929 cell response for cytotoxicity, Guinea Pig skin reaction for sensitization/irritation) as per ISO 10993 standards.
For Electrical Safety, EMC, Software: Compliance with recognized international standards (IEC 60601 series) and FDA guidance for software. The "ground truth" here is adherence to these engineering and regulatory standards.
For Clinical Efficacy (implied by Intended Use): The general understanding of "permanent hair reduction" as defined in the indications for use. However, no specific clinical "ground truth" (e.g., pathology reports of hair follicle counts, high-resolution imaging by a dermatologist, outcomes data) resulting from a study of this device is provided. The reliance is on the substantial equivalence to predicate devices that presumably did have such data for their original clearances.

8. The sample size for the training set:

Not applicable as no machine learning model or "training set" for AI is part of this device or its reported evaluation within this document.

9. How the ground truth for the training set was established:

Not applicable as no training set is relevant to this submission.

In summary, this 510(k) submission for the DUO, Model: IPL-HH380-IT, is based on demonstrating substantial equivalence to previously cleared predicate devices and compliance with relevant safety and performance standards rather than presenting new clinical efficacy data generated from a direct study of the DUO device against explicit clinical acceptance criteria.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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: 86-755 6121 8197 �
� Fax: 86-755 2598 1606
� Contact Person (including title): Yejuan
E-mail: info@steticsensebeauty.com �

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: +86-20-32136908 �
Email: Iris.Fung@sgs.com �

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

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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

6. Design

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 ofDevice RequiringBiocompatibility	Material ofComponent	Body ContactCategory(ISO 10993-1)	Contact Duration(ISO 10993-1)
Housing	PC 2805	Surface-contactingdevice: skin	Maximum 30minutes(< 24hours)
Output contacts	PC 2805	Surface-contactingdevice: skin	Maximum 30minutes(< 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.

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.

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.

1. Physical characteristics

Basic Unit Characteristics
Compliance* with 21 CFR 898	No
Main Unit Weight	280g
Main Unit Dimension	1307030mm
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°CHumidity: 30~~75%
Storage and Transport Conditions	Temperature: -15°C~~55°CHumidity: 10~~90%
Compliance with VoluntaryStandards	Yes,Comply with IEC 60601-1, IEC 60601-1-2,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 facialadaptor	Level 1:>7.7JLevel 2:>8.5JLevel 3:>9.4JLevel 4:>10.5JLevel 5:>12J
Output energy with facial adaptor	Level 1:>4.0JLevel 2:>4.7JLevel 3:>5.4JLevel 4:>5.9JLevel 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 ofComparison	Subject Device	Predicate Device	Remark
Device Name andModel	DUO, Model: IPL-HH380-IT	Lumena FH Hair RemovalSystem 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 MEDICALAESTHETICSDEVELOPMENT(SHENZHEN) CO.,LTD	Shaser, Inc.	EL Global Trade Ltd.	--
Intended Use	The DUO (Model: IPL-HH380-IT) is an over theCounter device intendedfor the removal ofunwanted body and/orfacial hair in adults. TheDUO is also intended forpermanent reduction inunwanted hair.Permanent hairreduction is defined asthe long-term stablereduction in the numberof hairs regrowing whenmeasured at 6. 9. and12 months after thecompletion of atreatment regimen.	Lumena FH is an over theCounter device intendedto providephototherapeutic light tothe body. It is alsointended for removal ofunwanted hair by using aselective photothermaltreatment. It is alsoindicated for the removalof unwanted body and/orfhcial hair in adultswith Fitzpatrick skin typesI - IV. The Lumena PH isalso intended forpermanent reduction inunwanted hair. Permanenthair reduction is definedas the long-term stablereduction in the number ofhairs regrowing whenmeasured at 6,9 and 12months after thecompletion of a treatmentregimen.	The sensi Light Mini isan over the counterdevices intended forthe removal ofunwanted hair. Thesensi Light Mini is alsointended forpermanent reduction inhair regrowth,defined as a long-term,stable reduction in thenumber of hairsregrowing whenmeasured at 6, 9 and12 months after thecompletion of atreatment regimen.	SE
Source Energy	Supplied by externaladapter	AC Mains	an external powersupply	SENote 1
'Use'Classification	OTC	OTC	OTC	SE
DeviceClassification	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	SENote 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 ofComparison	Subject Device	Predicate Device		Remark
Max. Fluence(J/cm2)	5 [Joules/cm²]	6 [Joules/cm²]	5 [Joules/cm²]	SENote 2
Spot Size (cm2)	3 [cm²]	2[cm²]	3 [cm²]	SENote 2
User Interface	LED Indicator lights	LED Indicator lights	LED Indicator lights	SE
Pulsing Control	Finger switch	Finger switch	Finger switch	SE
ControlMechanism	Microprocessor-basedControl	Microprocessor-basedControl	Microprocessor-basedControl	SE
Number of OutputChannels	One channel	One channel	One channel	SE

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Output IntensityLevel	5 levels	5 levels	--	SE
Software/Firmware/MicroprocessorControl?	Yes	Yes	Yes	SE
60601Compliancewith VoluntaryStandards	YesComply with IEC 60601-1 and IEC 60601-1-2,IEC60601-2-57	YesComply with IEC 60601-1and IEC 60601-1-2,IEC60601-2-57,	YesComply with IEC60601-1 and IEC60601-1-2,IEC60601-2-57,IEC60601-1-11	SE
Compliance* with21 CFR 898	No	No	No	SE
Weight	280g	1Kg	--	SENote 1
Dimensions	1307030mm	221678cm (HWD)	--	SENote 1
Standards
Biocompatibility	All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements.	All user directly contactingmaterials are compliancewith ISO10993-5 andISO10993-10requirements.	All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements.	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 ofComparison	Subject Device	Predicate Device	Remark
	IEC60601-1 andIEC60601-2-57	IEC 60601-1 andIEC 60601-2-57	IEC 60601-1 andIEC 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.

Page 20 of Report by STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD ട്ടു

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.