(87 days)
Not Found
No
The document describes a standard Intense Pulsed Light (IPL) system based on selective thermolysis principles, with no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The primary indications described are for aesthetic purposes (permanent hair reduction, reduction of benign pigmented lesions, and benign vascular lesions), not for treating diseases or medical conditions. While the device may impact biological processes, its stated uses are cosmetic or for benign conditions.
No
The device is used for permanent hair reduction and treatment of benign pigmented and vascular lesions, which are aesthetic and therapeutic applications, not diagnostic.
No
The device description explicitly states it is an "intense pulsed light system" and includes a "handpiece used to deliver pulsed-light energy," indicating it is a hardware device that utilizes intense pulsed light technology.
Based on the provided information, the VE2000 device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for surgical and aesthetic applications, specifically permanent hair reduction and reduction of benign pigmented and vascular lesions. This involves direct treatment of the patient's body using light energy.
- Device Description: The device is an intense pulsed light system that delivers light energy to the body. It works on the principle of selective thermolysis, targeting chromophores within the tissue.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health. The VE2000 does not perform any analysis on such specimens.
- Treatment, Not Diagnosis: The device is used for therapeutic and aesthetic purposes (treatment and modification of the body), not for diagnosing a disease or condition by analyzing biological samples.
In summary, the VE2000 is a therapeutic/aesthetic device that applies energy to the body, which is distinct from the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
ONF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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
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"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."
Type of Use (Select one or both, as applicable)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
3
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
-
- Date of Preparation: 07/31/2016
-
- 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
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
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
4
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 | |||
| and wave | ||||
| 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)
5
are indicated for use in surgical, aesthetic and cosmetic applications in permanent hair removal, reduction of pigmented lesions and vascular lesions.
-
- Identification of Predicate Device(s)
510(k) Number: K122995 Predicate Device Name: Intense Pulsed Light (IPL) Systems Manufacturer: Beijing KES Biology Technology Co., Ltd.
- Identification of Predicate Device(s)
-
- 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:
- Non-Clinical Test Conclusion
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
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
6
Substantially Equivalent (SE) Comparison 8.
| ITEM | Proposed Device
VE2000 | Predicate Device
Intense Pulsed Light (IPL)
Systems(K122995) | Remark |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | ONF | ONF | SE |
| Regulation
No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | II | II | SE |
| 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 | Intense Pulsed Light (IPL) Systems
(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,
acne therapy, freckles, vascular
lesions and facial blemish. | SE |
Table 9-1 General Comparison
7
| ITEM | Proposed Device
VE2000 | Predicate Device
Intense Pulsed Light (IPL)
Systems(K122995) | Remark |
|----------------|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------|
| Light source | Intense pulsed light | Intense pulsed light | SE |
| Wavelength | 480nm-1200nm
590nm-1200nm
640nm-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 Device
VE2000 | Predicate Device
Intense 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; 15mmX50mm
15mmX35mm | |
| 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
8
| Pulse Delay (ms) | 16-32 | 16-32 | |
|---|---|---|---|
| Spot Size (mm) | 12x30mm | 12mm X33mm; 15mmX50mm | |
| 15mmX35mm | |||
| 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; 15mmX50mm | |
| 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
VE2000 | Predicate Device
Intense Pulsed Light (IPL)
Systems(K122995) | Remark |
|-----------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------|
| Power supply | 110V 50Hz | 220V±20V 50Hz or
110V±20V 60Hz | SE |
| Electrical
Safety | The proposed devices were
tested to demonstrated to
comply with IEC 60601-1 | The proposed devices were
tested to demonstrated to
comply with IEC 60601-1 | SE |
| EMC | The proposed devices were
tested to demonstrated to
comply with IEC 60601-1-2 | The proposed devices were
tested to demonstrated to
comply with IEC 60601-1-2 | SE |
| Patient Contact
Material | Handpiece | Handpiece | SE |
| Cytotoxicity | No toxicity (ISO 10993-5) | No toxicity (ISO 10993-5) | SE |
| Irritation | Applied sample did not
induce irritation to skin. (ISO
10993-10) | Applied sample did not induce
irritation to skin. (ISO
10993-10) | SE |
| Sensitization | The test article showed no
signification evidence of | The test article showed no
signification evidence of | SE |
9
| 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.