IPL Therapy Machine

K161286 · Beijing Adss Development Co., Ltd. · ONF · Aug 4, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K161286
• Device Name: IPL Therapy Machine
• Applicant: Beijing Adss Development Co., Ltd.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Aug 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

VE2000 is an intense pulsed light (IPL) system delivering light (480nm-1200nm) via a sapphire handpiece; operates on selective thermolysis principle; causes thermal damage to target chromophores while sparing normal skin by limiting pulse width below thermal relaxation time. Used in clinical settings by trained operators for hair removal and lesion reduction. Device produces pulsed light energy; provider selects wavelength filters and energy parameters based on skin type and condition. Benefits include non-invasive aesthetic treatment for hair and skin lesions.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance requirements for non-laser light sources (IEC 60601-2-57), alongside biocompatibility testing (ISO 10993-5, ISO 10993-10).

Technological Characteristics

IPL system; wavelength 480-1200nm; sapphire delivery system; max power 2200W; energy density 1-50J/cm²; pulse width 1-25ms; pulse delay 1-50ms. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-57. Biocompatible handpiece materials (ISO 10993).

Indications for Use

Indicated for permanent hair reduction, reduction of benign pigmented lesions, and benign vascular lesions in patients requiring surgical or aesthetic treatment.

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

• Intense Pulsed Light (IPL) Systems (K122995)

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 & 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 [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 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

| <span> <span style="font-size: 12px;"> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> | <span> <span style="font-size: 12px;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|

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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
- 2. 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: [phone] Fax:[phone] Email: [e-mail]

- 3. 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: [phone] Fax: [phone] Email: [e-mail]

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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 setting<br>and wave<br>length 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:

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)

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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.

- 5. Identification of Predicate Device(s)
510(k) Number: K122995 Predicate Device Name: Intense Pulsed Light (IPL) Systems Manufacturer: Beijing KES Biology Technology Co., Ltd.

- 6. 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

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

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#### Substantially Equivalent (SE) Comparison 8.

| ITEM | Proposed Device<br>VE2000 | Predicate Device<br>Intense Pulsed Light (IPL)<br>Systems(K122995) | Remark |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | ONF | ONF | SE |
| Regulation<br>No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | II | II | SE |
| Intended Use | The VE2000 device is indicated<br>for use in surgical, aesthetic<br>applications in permanent hair<br>reduction, reduction of benign<br>pigmented lesions and benign<br>vascular lesions.<br>Permanent hair reduction is<br>defined as the long-term, stable<br>reduction in the number of hairs<br>regrowing when measured at 6, 9,<br>and 12 months after the<br>completion of a treatment regimen | Intense Pulsed Light (IPL) Systems<br>(inclusive of the handpiece used to<br>deliver pulsed-light energy) are<br>indicated for use in surgical,<br>aesthetic and cosmetic applications<br>in permanent hair removal,<br>reduction of pigmented lesions,<br>acne therapy, freckles, vascular<br>lesions and facial blemish. | SE |

# Table 9-1 General Comparison

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| ITEM | Proposed Device<br>VE2000 | Predicate Device<br>Intense Pulsed Light (IPL)<br>Systems(K122995) | Remark |
|----------------|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------|
| Light source | Intense pulsed light | Intense pulsed light | SE |
| Wavelength | 480nm-1200nm<br>590nm-1200nm<br>640nm-1200nm | 430-1200nm, 530-1200nm,<br>640-1200nm,<br>Optional: 480-1200nm,<br>560-1200nm, 590-1200nm,<br>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<br>(optional: 12mmX33mm,<br>15mmX35mm )<br>MED-230:<br>A: 12mm X33mm;<br>B: 15mmX50mm (optional:<br>15mmX35mm) | Analysis 1 |

Table 9-2 Performance Comparison

| ITEM | Proposed Device<br>VE2000 | Predicate Device<br>Intense Pulsed Light (IPL)<br>Systems(K122995) | Remark |
|--------------------------|---------------------------|--------------------------------------------------------------------|--------|
| permanent hair reduction | | | |
| Wavelength Range<br>(nm) | 640-1200 | 640-1200/690-1200/ 750-1200 | |
| Energy Range<br>(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; 15mmX50mm<br>15mmX35mm | |
| pigmented lesions | | | |
| Wavelength Range<br>(nm) | 480-1200 | 480-1200/530-1200/560-1200 | |
| Energy Range<br>(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; 15mmX50mm<br>15mmX35mm | |
| vascular lesions | | | |
| Wavelength Range (nm) | 590-1200 | 530-1200/560-1200/<br>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; 15mmX50mm<br>15mmX35mm | |

### 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 Device<br>VE2000 | Predicate Device<br>Intense Pulsed Light (IPL)<br>Systems(K122995) | Remark |
|-----------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------|
| Power supply | 110V 50Hz | 220V±20V 50Hz or<br>110V±20V 60Hz | SE |
| Electrical<br>Safety | The proposed devices were<br>tested to demonstrated to<br>comply with IEC 60601-1 | The proposed devices were<br>tested to demonstrated to<br>comply with IEC 60601-1 | SE |
| EMC | The proposed devices were<br>tested to demonstrated to<br>comply with IEC 60601-1-2 | The proposed devices were<br>tested to demonstrated to<br>comply with IEC 60601-1-2 | SE |
| Patient Contact<br>Material | Handpiece | Handpiece | SE |
| Cytotoxicity | No toxicity (ISO 10993-5) | No toxicity (ISO 10993-5) | SE |
| Irritation | Applied sample did not<br>induce irritation to skin. (ISO<br>10993-10) | Applied sample did not induce<br>irritation to skin. (ISO<br>10993-10) | SE |
| Sensitization | The test article showed no<br>signification evidence of | The test article showed no<br>signification 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.