The VE2000 device is indicated for use in surgical, aesthetic applications in permanent hair 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

Device Description

The VE2000 device are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 480nm-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 Systems 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.

Based on this,The VE2000 device (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in permanent hair removal, reduction of pigmented lesions and vascular lesions.

AI/ML Overview

The provided document outlines the substantial equivalence (SE) determination for the VE2000 IPL Therapy Machine (K161286) to a predicate device (Intense Pulsed Light (IPL) Systems, K122995).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" for clinical performance. Instead, it demonstrates substantial equivalence by comparing the proposed VE2000 device's performance parameters and intended uses to those of a legally marketed predicate device. The underlying "acceptance criteria" are therefore implied to be that the proposed device performs comparably to the predicate device for its stated indications.

Parameter/Characteristic	Acceptance Criteria (Implied from Predicate)	Reported Device Performance (VE2000)	Meets Criteria	Notes on Comparison
Product Code	ONF	ONF	Yes	Substantially Equivalent (SE)
Regulation No.	21 CFR 878.4810	21 CFR 878.4810	Yes	SE
Class	II	II	Yes	SE
Intended Use (Overall)	Surgical, aesthetic, and cosmetic applications in permanent hair removal, reduction of pigmented lesions, acne therapy, freckles, vascular lesions and facial blemish.	Surgical, aesthetic applications in permanent hair reduction, reduction of benign pigmented lesions and benign vascular lesions.	Yes	SE (Proposed device has a narrower IFU scope, making it SE)
Light Source	Intense pulsed light	Intense pulsed light	Yes	SE
Wavelength	430-1200nm, 530-1200nm, 640-1200nm, Optional: 480-1200nm, 560-1200nm, 590-1200nm, 690-1200nm, 750 -1200nm	480nm-1200nm, 590nm-1200nm, 640nm-1200nm	Yes	SE (Ranges overlap substantially, and proposed device ranges fall within or are comparable to predicate's capabilities)
Delivery System	Sapphire	Sapphire	Yes	SE
Energy Density	10-60 J/cm²	1-50 J/cm²	Yes, with analysis	Analysis 1: "the difference is very slight, and only in the range, but because the proposed device has narrow IFU scope and same IFU setting with the predicate device, the current parameter range is available for the indication for use of proposed device." Considered SE.
Pulse Delay	5-50 ms	1-50 ms	Yes, with analysis	Analysis 1: "the difference is very slight, and only in the range... Considered SE.
Pulse Width	1-20 ms	1-25 ms	Yes, with analysis	Analysis 1: "the difference is very slight, and only in the range... Considered SE.
Max. Power	2000 W	2200 W	Yes	SE (Slight increase, likely not detrimental for a Class II device)
Spot Size	MED-210: 15mmX50mm (optional: 12mmX33mm, 15mmX35mm); MED-230: A: 12mm X33mm; B: 15mmX50mm (optional: 15mmX35mm)	12x30mm	Yes, with analysis	Analysis 1: "the difference is very slight, and only in the range... Considered SE.
Permanent Hair Reduction Settings:
- Wavelength Range (nm)	640-1200/690-1200/750-1200	640-1200	Yes	Comparison shows overlap and acceptable ranges.
- Energy Range (J/cm²)	10-44	10-44	Yes	SE
- Pulse Width (ms)	3-14	3-14	Yes	SE
- Pulse Delay (ms)	16-32	16-32	Yes	Comparison shows overlap and acceptable ranges.
- Spot Size (mm)	12mm X33mm; 15mmX50mm; 15mmX35mm	12x30mm	Yes	Comparison shows overlap and acceptable ranges.
Pigmented Lesions Settings:
- Wavelength Range (nm)	480-1200/530-1200/560-1200	480-1200	Yes	Comparison shows overlap and acceptable ranges.
- Energy Range (J/cm²)	12-44	12-44	Yes	SE
- Pulse Width (ms)	3-9	3-9	Yes	Comparison shows overlap and acceptable ranges.
- Pulse Delay (ms)	16-32	16-32	Yes	Comparison shows overlap and acceptable ranges.
- Spot Size (mm)	12mm X33mm; 15mmX50mm; 15mmX35mm	12x30mm	Yes	Comparison shows overlap and acceptable ranges.
Vascular Lesions Settings:
- Wavelength Range (nm)	530-1200/560-1200/590-1200	590-1200	Yes	Comparison shows overlap and acceptable ranges.
- Energy Range (J/cm²)	10-42	10-42	Yes	SE
- Pulse Width (ms)	3-8	3-8	Yes	Comparison shows overlap and acceptable ranges.
- Pulse Delay (ms)	16-32	16-32	Yes	Comparison shows overlap and acceptable ranges.
- Spot Size (mm)	12mm X33mm; 15mmX50mm; 15mmX35mm	12x30mm	Yes	Comparison shows overlap and acceptable ranges.
Electrical Safety	Compliance with IEC 60601-1	Compliance with IEC 60601-1	Yes	SE
EMC	Compliance with IEC 60601-1-2	Compliance with IEC 60601-1-2	Yes	SE
Patient Contact Material	Handpiece	Handpiece	Yes	SE
Cytotoxicity	No toxicity (ISO 10993-5)	No toxicity (ISO 10993-5)	Yes	SE
Irritation	No irritation to skin (ISO 10993-10)	No irritation to skin (ISO 10993-10)	Yes	SE
Sensitization	No significant evidence of sensitization (ISO 10993-10)	No significant evidence of sensitization (ISO 10993-10)	Yes	SE

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical study is included in this submission."

Therefore, there is no test set sample size or data provenance related to clinical performance described. The safety and effectiveness determination is based on non-clinical testing and comparison to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical study was conducted and no clinical test set was used for performance evaluation, this information is not applicable and is not provided in the document.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission relies on non-clinical testing and substantial equivalence to a predicate device, without involving human readers or AI assistance in a comparative effectiveness study.

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

Not applicable. The device is an IPL Therapy Machine, not an algorithm, and its performance evaluation for substantial equivalence was based on non-clinical testing and comparison to a physical predicate device, not standalone algorithmic performance.

7. The Type of Ground Truth Used

The "ground truth" for the substantial equivalence determination for this device is primarily established by:

Compliance with recognized electrical safety and EMC standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57.
Biocompatibility testing: ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
Direct functional and parametric comparison to a legally marketed predicate device (K122995) for intended use, light source, wavelength, energy density, pulse characteristics, and spot size. The predicate device itself has presumably been accepted by the FDA based on its own evidence of safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This device is an IPL therapy machine, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

August 4, 2016

Beijing Adss Development Co., Ltd % Ray Wang General Manager Beijing Believe Technology Services Co., Ltd. 5-1206. Build 332. Dafangiu. No.25 Banbidian Rd. Liyuan Town, Tongzhou District, Beijing, 101121 CN

Re: K161286

Trade/Device Name: Ipl Therapy 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 Dated: May 3, 2016 Received: May 9, 2016

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. 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

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (21 CFR Part 801), 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 vours.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K161286

Device Name

IPL Therapy Machine

Indications for Use (Describe)

The VE2000 device is indicated for use in surgical, aesthetic applications in permanent hair 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

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------

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Tab #7 510(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: K161286

1. Date of Preparation: 07/31/2016
1. Sponsor Identification

Beijing ADSS Development Co., Ltd

F6, Xiandao Bldg., Jinyuan Rd. 36, Daxing Economic Development zone, Beijing, China, 102628

Establishment Registration Number: Not yet registered or the Number

Contact Person: Gao Yurong Position: sales manager Tel: 86-10-83625120 Fax:86-10-83625121 Email: gyr@adss.com.cn

1. Designated Submission Correspondent
  Mr. Ray Wang

Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China

Tel: +86-10-59120817 Fax: +86-10-52214696 Email: ray.wang@believe-med.com

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4. Identification of Proposed Device

Trade Name: IPL Therapy Machine

Common Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Model(s): VE2000

Regulatory Information:

Classification Name:

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

Classification: II; Product Code: ONF;

Regulation Number: 21 CFR 878.4810;

Review Panel: General & Plastic Surgery;

Intended Use Statement:

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.

		Skin Types
Conditions	Filter settingand wavelength rang	I	II	III
hair removal		640-1200	640-1200	640-1200
pigmented lesions		480-1200	480-1200	480-1200
vascular lesions		590-1200	590-1200	590-1200

Device Description:

Based on this,The VE2000 device (inclusive of the handpiece used to deliver pulsed-light energy)

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are indicated for use in surgical, aesthetic and cosmetic applications in permanent hair removal, reduction of pigmented lesions and vascular lesions.

1. Identification of Predicate Device(s)
  510(k) Number: K122995 Predicate Device Name: Intense Pulsed Light (IPL) Systems Manufacturer: Beijing KES Biology 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:

a)IEC 60601-1-2:2007, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.

b)IEC 60601-1:2005/A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

c)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

1. Clinical Test Conclusion
  No clinical study is included in this submission.

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Substantially Equivalent (SE) Comparison 8.

ITEM	Proposed DeviceVE2000	Predicate DeviceIntense Pulsed Light (IPL)Systems(K122995)	Remark
Product Code	ONF	ONF	SE
RegulationNo.	21 CFR 878.4810	21 CFR 878.4810	SE
Class	II	II	SE
Intended Use	The VE2000 device is indicatedfor use in surgical, aestheticapplications in permanent hairreduction, reduction of benignpigmented lesions and benignvascular lesions.Permanent hair reduction isdefined as the long-term, stablereduction in the number of hairsregrowing when measured at 6, 9,and 12 months after thecompletion of a treatment regimen	Intense Pulsed Light (IPL) Systems(inclusive of the handpiece used todeliver pulsed-light energy) areindicated for use in surgical,aesthetic and cosmetic applicationsin permanent hair removal,reduction of pigmented lesions,acne therapy, freckles, vascularlesions and facial blemish.	SE

Table 9-1 General Comparison

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ITEM	Proposed DeviceVE2000	Predicate DeviceIntense Pulsed Light (IPL)Systems(K122995)	Remark
Light source	Intense pulsed light	Intense pulsed light	SE
Wavelength	480nm-1200nm590nm-1200nm640nm-1200nm	430-1200nm, 530-1200nm,640-1200nm,Optional: 480-1200nm,560-1200nm, 590-1200nm,690-1200nm, 750 -1200nm	SE
Deliver system	Sapphire	Sapphire	SE
Energy density	1-50J/cm²	10-60J/cm²	Analysis 1
Pulse Delay	1-50ms	5 - 50ms	Analysis 1
Pulse Width	1-25ms	1-20ms	Analysis 1
Max. Power	2200W	2000 W	SE
Spot size	12x30mm	MED-210: 15mmX50mm(optional: 12mmX33mm,15mmX35mm )MED-230:A: 12mm X33mm;B: 15mmX50mm (optional:15mmX35mm)	Analysis 1

Table 9-2 Performance Comparison

ITEM	Proposed DeviceVE2000	Predicate DeviceIntense Pulsed Light (IPL)Systems(K122995)	Remark
permanent hair reduction
Wavelength Range(nm)	640-1200	640-1200/690-1200/ 750-1200
Energy Range(J/cm2)	10-44	10-44
Pulse Width (ms)	3-14	3-14	SE
Pulse Delay (ms)	16-32	16-32
Spot Size (mm)	12x30mm	12mm X33mm; 15mmX50mm15mmX35mm
pigmented lesions
Wavelength Range(nm)	480-1200	480-1200/530-1200/560-1200
Energy Range(J/cm2)	12-44	12-44	SE
Pulse Width (ms)	3-9	3-9

Table 9-3 Setting Comparison of Specified Indication for Use

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Pulse Delay (ms)	16-32	16-32
Spot Size (mm)	12x30mm	12mm X33mm; 15mmX50mm15mmX35mm
vascular lesions
Wavelength Range (nm)	590-1200	530-1200/560-1200/590-1200
Energy Range (J/cm2)	10-42	10-42	SE
Pulse Width (ms)	3-8	3-8
Pulse Delay (ms)	16-32	16-32
Spot Size (mm)	12x30mm	12mm X33mm; 15mmX50mm15mmX35mm

Analysis 1:

The Energy density, Pulse width and Pulse delay of proposed device is very similar to that of predicate device, the difference is very slight, and only in the range, but because the proposed device has narrow IFU scope and same IFU setting with the predicate device, the current parameter range is available for the indication for use of proposed device. Therefore, the slight difference is considered to have no effect on effectiveness and safe.

ITEM	Proposed DeviceVE2000	Predicate DeviceIntense Pulsed Light (IPL)Systems(K122995)	Remark
Power supply	110V 50Hz	220V±20V 50Hz or110V±20V 60Hz	SE
ElectricalSafety	The proposed devices weretested to demonstrated tocomply with IEC 60601-1	The proposed devices weretested to demonstrated tocomply with IEC 60601-1	SE
EMC	The proposed devices weretested to demonstrated tocomply with IEC 60601-1-2	The proposed devices weretested to demonstrated tocomply with IEC 60601-1-2	SE
Patient ContactMaterial	Handpiece	Handpiece	SE
Cytotoxicity	No toxicity (ISO 10993-5)	No toxicity (ISO 10993-5)	SE
Irritation	Applied sample did notinduce irritation to skin. (ISO10993-10)	Applied sample did not induceirritation to skin. (ISO10993-10)	SE
Sensitization	The test article showed nosignification evidence of	The test article showed nosignification evidence of	SE

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causing skin sensitization in	causing skin sensitization in
the guinea pig.(ISO 10993-10)	the guinea pig. (ISO 10993-10)

Substantially Equivalent (SE) Conclusion 9.

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

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.