The IPL + Diode Laser machine (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical, and aesthetic applications in permanent hair reduction of benign pigmented lesions and benign vascular lesions, and (inclusive of the handpiece used to deliver diode laser energy) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Device Description

The proposed device, IPL + Diode Laser machine (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical, and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions, and (inclusive of the handpiece used to deliver diode laser energy)is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

IPL are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 480mm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.

IPL are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.

Diode Laser machine is based on the principles of selective photothermolysis (SPTL): a combination of the appropriate laser wavelength, pulse duration, and fluence can obtain optimal effect on a targeted tissue with minimal effect on surrounding tissue.

Wavelengths of 808 nanometers (nm) are widely used in hair removal treatment, it is selectively absorbed by melanin in the hair shaft, damaging the follicular epithelium, and further causes hair loss, while the competing chromophores (oxyhemoglobin and water) absorb less energy at these wavelengths.

The user could power on the device and use the key switch to start the system, and then set the output parameter, when the setting is done, the user could use the handpiece to aim the area to be treated by 808 nm laser delivering , the laser emitting could be triggered by foot switch controlled by user.

Function module description: Control Panel, Main Control Module, Constant current board module, Temperature and humidity control system, Handpiece module.

AI/ML Overview

This document is a 510(k) Summary for a medical device (IPL + Diode Laser Machine) seeking FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study for a novel AI/software medical device.

Therefore, most of the requested information for an AI/software medical device (like acceptance criteria for AI performance metrics, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable to this document.

However, I can extract information related to the device's non-clinical performance and the demonstration of its safety and effectiveness relative to predicates.

Here's what can be extracted and what cannot be for this specific document:

Information that CANNOT be extracted from this document (due to the nature of the device and submission type):

A table of acceptance criteria and the reported device performance (for AI/software performance metrics): This document does not describe acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC) or report those metrics. It focuses on the device's physical and functional specifications.
Sample sized used for the test set and the data provenance: No test set in the context of AI/software performance is mentioned. The "tests" refer to compliance with electrical, laser, and biocompatibility standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted reading device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for AI performance ground truth.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Information that CAN be extracted regarding the device's non-clinical performance and comparison to predicates:

1. A table of acceptance criteria and the reported device performance
(Note: These are non-clinical hardware/physical criteria, not AI performance metrics)

Acceptance Criteria (Predicate Device Values)	Reported Device Performance (Proposed Device)	Remark/Comparison Outcome
IPL Performance
Energy density: 1-50 J/cm²	1-40 J/cm²	Analysis 1 (Different, but guaranteed by standards compliance)
Max. Power: 2200W	2200 VA	SE (Substantially Equivalent)
Wavelength (hair reduction): 640-1200 nm	640-1200 nm	SE
Energy Range (hair reduction): 10-44 J/cm²	11-40 J/cm²	Analysis 1 (Different, but guaranteed by standards compliance)
Pulse Width (hair reduction): 3-14 ms	16-32 ms	Analysis 1 (Different, but guaranteed by standards compliance)
Pulse Delay (hair reduction): 16-32 ms	5-14 ms	Analysis 1 (Different, but guaranteed by standards compliance)
Spot Size (hair reduction): 12*30 mm²	15*50 mm²	Analysis 1 (Different, but guaranteed by standards compliance)
Wavelength (pigmented lesions): 480-1200 nm	480-1200 nm	SE
Energy Range (pigmented lesions): 12-44 J/cm²	10-40 J/cm²	Analysis 1 (Different, but guaranteed by standards compliance)
Pulse Width (pigmented lesions): 3-9 ms	16-32 ms	Analysis 1 (Different, but guaranteed by standards compliance)
Pulse Delay (pigmented lesions): 16-32 ms	3-8 ms	Analysis 1 (Different, but guaranteed by standards compliance)
Spot Size (pigmented lesions): 12*30 mm²	15*50 mm²	Analysis 1 (Different, but guaranteed by standards compliance)
Wavelength (vascular lesions): 590-1200 nm	590-1200 nm	SE
Energy Range (vascular lesions): 10-42 J/cm²	10-40 J/cm²	Analysis 1 (Different, but guaranteed by standards compliance)
Pulse Width (vascular lesions): 3-8 ms	16-32 ms	Analysis 1 (Different, but guaranteed by standards compliance)
Pulse Delay (vascular lesions): 16-32 ms	5-9 ms	Analysis 1 (Different, but guaranteed by standards compliance)
Spot Size (vascular lesions): 12*30 mm²	15*50 mm²	Analysis 1 (Different, but guaranteed by standards compliance)
Diode Laser Performance
Laser Type: Diode Laser	Diode Laser	SE
Laser Classification: Class IV	Class IV	SE
Laser Wavelength: 808 nm	808 nm	SE
Spot Size: 1.2 cm²	13*13mm² (1.69 cm²)	Analysis 2 (Different, but guaranteed by standards compliance)
Fluence: 1-70 J/cm²	1-69 J/cm²	Analysis 2 (Different, but guaranteed by standards compliance)
Frequency: 1-20 Hz	SHR: 1-10 Hz, LHR: 1-3 Hz	Analysis 2 (Different, but guaranteed by standards compliance)
Pulse Duration: 5-400 ms	5-400 ms	SE
Safety & Biocompatibility
Cytotoxicity: No Cytotoxicity	No Cytotoxicity	SE
Sensitization: No evidence of sensitization	No evidence of sensitization	SE
Irritation: No evidence of irritation	No evidence of irritation	SE
Electrical Safety: Comply with IEC 60601-1, IEC 60601-2-22, IEC60601-2-57 (overall for both IPL & Diode Laser)	Comply with IEC 60601-1, IEC 60601-2-22, IEC60601-2-57	SE
EMC: Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	SE
Laser Safety: Comply with IEC 60601-2-22, IEC 60825 (overall for both)	Comply with IEC 60601-2-22, IEC 60825, IEC60601-2-57	SE
Power Supply: AC 110V 50Hz / AC 110V/60Hz or 250V 50Hz	AC110V, 50/60Hz	SE
Dimension (Predicate 1): 430x 590 x 1360 mm, (Predicate 2): 598x440x1093mm	620x610x1290mm	Analysis 3 (Different, but determined not to affect safety/effectiveness)
Weight (Predicate 1): 45kg, (Predicate 2): 60Kg	78kg	Analysis 3 (Different, but determined not to affect safety/effectiveness)

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

Test Set Sample Size: Not applicable. The "tests" mentioned are for compliance with recognized electrical, laser, and biocompatibility standards (e.g., IEC 60601 series, ISO 10993 series). These tests are typically performed on the device itself and its components, not on a "test set" of patient data for AI performance evaluation.
Data Provenance: Not applicable.

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

Not applicable. This device is cleared based on substantial equivalence to existing devices, relying on non-clinical engineering and safety standards, not on AI performance requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

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:

No MRMC study was done (or required) as this is not an AI-assisted reading device. The document explicitly states: "No clinical study is included in this submission."

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

Not applicable. This device is a physical IPL+Laser machine, not a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

For the purpose of this 510(k), the "ground truth" for demonstrating substantial equivalence is the existing predicate devices and compliance with recognized international standards for medical electrical equipment, laser products, and biocompatibility. There is no patient-data-driven ground truth in the context of AI performance for this submission.

8. The sample size for the training set:

Not applicable. This device does not use an AI training set.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

March 25, 2020

Beijing Globalipl Development 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, 102401 Cn

Re: K193328

Trade/Device Name: IPL + Diode Laser Machine 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, GEX Dated: November 29, 2019 Received: December 2, 2019

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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jessica Mavadia-Shukla, PhD Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K193328

Device Name Trade Name: IPL + Diode Laser machine Model: US419

Type of Use (Select one or both, as applicable)

Indications for Use (Describe)

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.

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 PRAStaff@fda.hhs.gov

"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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Tab #8 510(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: K193328

1. Date of Preparation
  02/28/2020
Sponsor 2.

Beijing Globalipl Development Co.,Ltd.

F-8 Qunyinghui Building, Jinyuan Rd.32, Daxing Economic Development Zone, Beijing, China 102628

Contact Person: Li Ye Position: Certification Department Manager Tel: +86-18865721581 Fax: +86-534-2756245 Email: Liye@globalipl.com

1. Submission Correspondent
  Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401

Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com

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4. Identification of Proposed Device

Trade Name: IPL + Diode Laser machine Common Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect; Powered Laser Surgical Instrument Model(s): US419

Regulatory Information:

Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology ;

Classification: II;

Product Code: ONF, GEX;

Regulation Number: 21 CFR 878.4810;

Review Panel: General & Plastic Surgery;

Indication For Use:

The IPL + Diode Laser machine (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical, and aesthetic applications in permanent hair reduction, reduction of benign pigmented lesions and benign vascular lesions, and (inclusive of the handpiece used to deliver diode laser energy)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.

ર. Device Description

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Function module description

a. Control Panel

The module uses the microcontroller as the heart, utilizes the LCD screen to display all prompt information and the system state information to complete the human-machine interaction function, and realizes the device parameters settings and accurate control of the output IPL/laser energy by the operator.

b. Main Control Module

The module uses the microcontroller as the heart, receives the IPL/laser energy parameters and work instructions from the control panel and detects the footswitch state; Utilizes the sensors of temperature, humidity, liquid level and flow to detect the parameters such as temperature, humidity and water flow during system working, and according to the detected values to calculate the dew point temperature; Controls and detects the work state of constant current board module as well as the temperature and humidity control system; Uploads the state data and alarm information of water circulation system, cooling system, handpiece module and constant current board module during system working.

c. Constant current board module

The module uses the high-power MOS as the heart, receives the IPL/laser energy parameters from the main control module, supplies the IPL/laser with constant drive current which corresponding to the received IPL/laser energy parameters to drive the IPL/laser to emit light. The module also has the detection function of over-current, over-voltage, over-temperature and handpiece state, and uploads the detected data to the control module.

d. Temperature and humidity control system

The system mainly includes the condenser, cold plate, water circulation subsystem and fans. The microcontroller of main control module according to the temperature, humidity parameter detected by the sensors to control the working state of the condenser, cold plate and cooling fan to meet the temperature and humidity requirements during the IPL/laser working.

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e. Handpiece module

Handpiece module is the heart of the device, which is the execution unit of the device and completes the IPL/laser emission function. The module is mainly composed of IPL/laser, sapphire, temperature and humidity sensor, data storage chips, cooling components and water flow path. The IPL/laser emits light to output energy, temperature and humidity sensors detects the temperature and humidity parameters during handpiece working, the cooling components and water flow path take away the heat of the IPL/laser to prevent it from being damaged caused by over-temperature, so prolongs the service life of the IPL/laser.

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1. Identification of Predicate Device Predicate Device 1: 510(k) Number: K161286 Product Name: IPL Therapy Machine Manufacturer: BEIJING ADSS DEVELOPMENT CO., LTD.
  Predicate Device 2: 510(k) Number: K192516 Product Name: Diode Laser 808nm Manufacturer: Beijing Superlaser Technology Co., Ltd.
1. 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:
IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
IEC 60601-2-22 Edition 3.1 2012-10, 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.
IEC60601-2-57:2011, Medical electrical equipment -- Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems
IEC 60601-1-2:2014 , Medical electrical equipment Part 1-2: General requirements for basic A safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)
Clinical Test Conclusion 8.

No clinical study is included in this submission.

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9. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate Device 1K161286	Predicate Device 2K192516	Remark
Product Code	ONF;GEX	ONF	GEX	SE
Regulation Number	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	SE
Intended Use	The IPL + Diode Laser machine (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical, and aesthetic applications in permanent hair reduction, reduction of benign pigmented lesions and benign vascular lesions, and (inclusive of the handpiece used to deliver diode laser energy)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 VE2000 device is indicated for use in surgical, aesthetic applications in permanent hair reduction, reduction of benign pigmented lesions and benign vascular lesions. 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	The Diode Laser 808nm 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.	SE
Configuration	Main UnitHandpieceFoot Control	Main UnitHandpieceFoot Control	Main UnitHandpieceFoot Control	SE
ITEM	Proposed Device	Predicate Device1IPL Therapy Machine(K161286)	Remark
Light source	Intense pulsed light	Intense pulsed light	SE
Wavelength	480-1200 nm590-1200 nm640-1200 nm	480nm-1200nm590nm-1200nm640nm-1200nm	SE
Deliver system	Sapphire	Sapphire	SE
Energy density	1~40J/cm2	1-50J/cm²	Analysis 1
Max. Power	2200VA	2200W	SE
permanent hair reduction
Wavelength Range (nm)	640-1200	640-1200	SE
Energy Range (J/cm²)	11-40	10-44	Analysis 1
Pulse Width (ms)	16-32	3-14	Analysis 1
Pulse Delay (ms)	5-14	16-32	Analysis 1
Spot Size (mm²)	15*50	12*30	Analysis 1
pigmented lesions
Wavelength Range (nm)	480-1200	480-1200	SE
Energy Range (J/cm²)	10-40	12-44	Analysis 1
Pulse Width (ms)	16-32	3-9	Analysis 1
Pulse Delay (ms)	3-8	16-32	Analysis 1
Spot Size (mm²)	15*50	12*30	Analysis 1
vascular lesions
Wavelength Range (nm)	590-1200	590-1200	SE
Energy Range (J/cm²)	10-40	10-42	Analysis 1
Pulse Width (ms)	16-32	3-8	Analysis 1
Pulse Delay (ms)	5-9	16-32	Analysis 1
Spot Size (mm²)	15*50	12*30	Analysis 1

Table 7-1 General Comparison

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Table 7-2 Performance Comparison(IPL)

Analysis 1

The proposed device is different in energy density, energy range, pulse width and pulse delay from the predicate device. Buy the IPL system of the proposed device has passed the IEC60601-2-57 and IEC62471 test, the IPL performance of the proposed device can be guaranteed. By complying with non-clinical test conducted, the proposed device is determined to be substantially equivalency with predicate device.

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Item	Proposed Device	Predicate Device 2Diode Laser 808nmK192516	Remark
Laser Type	Diode Laser	Diode Laser	SE
Laser Classification	Class IV	Class IV	SE
Laser Wavelength	808 nm	808 nm	SE
Spot Size	13*13mm²	1.2 cm²	Analysis 2
Fluence	1~69J/c m²	1-70J/ cm²	Analysis 2
Frequency	SHR:1-10HzLHR:1-3 Hz	1-20 Hz	Analysis 2
	Pulse Duration	5~400ms	5~400ms

	Table 7-3 Performance Comparison (Diode Laser )
--	-------------------------------------------------	--	--	--

Analysis 2

The proposed device is different in Spot Size, Fluence, Frequency and Pulse Duration from the predicate device. Buy the Diode Laser system of the proposed device has passed the IEC60601-2-22 and IEC60825-1 test, the Diode Laser performance of the proposed device can be guaranteed. By complying with non-clinical test conducted, the proposed device is determined to be substantially equivalency with predicate device.

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		Predicate Device1	Predicate Device 2
Item	Proposed Device	IPL Therapy	Diode Laser 808nm	Remark
		Machine (K161286)	(K192516)
Patient Contact Materials and Biocompatibility
PatientContactMaterials	IPL + Diode Laserhandpiece	IPL handpiece	Diode Laser handpiece	SE
Cytotoxicity	No Cytotoxicity	No Cytotoxicity	No Cytotoxicity
Sensitization	No evidence ofsensitization	No evidence ofsensitization	No evidence ofsensitization	SE
Irritation	No evidence ofirritation	No evidence ofirritation	No evidence ofirritation
EMC, Electrical and Laser Safety
ElectricalSafety	Comply with IEC60601-1, IEC60601-2-22,IEC60601-2-57	Comply with IEC60601-1	Comply with IEC60601-1, IEC60601-2-22	SE
EMC	Comply with IEC60601-1-2	Comply with IEC60601-1-2	Comply with IEC60601-1-2	SE
Laser Safety	Comply withIEC 60601-2-22,IEC 60825 ,IEC60601-2-57	Comply withIEC60601-2-57	Comply with IEC60601-2-22, IEC60825	SE
Power Supply	AC110V,50/60Hz	AC 110V 50Hz	AC 110V/60Hz or250V 50Hz	SE
Dimension	620x610x1290mm	430x 590 x 1360 mm	598x440x1093mm	Analysis 3
Weight	78kg	45kg	60Kg	Analysis 3

		Table 7-4 Safety Comparison
	้

Analysis 3

The proposed device is different in Dimension and Weight from the predicate device. but the proposed device has passed the IEC 60601-1-2, IEC 60601-2-22, IEC60601-2-57, IEC 60825 test, we believe these differences will not affect the effectiveness and safety compared with the predicate device., the proposed device is determined to be substantially equivalency with predicate device.

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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.

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.