(114 days)
Not Found
No
The summary describes a standard IPL and Diode Laser device based on established principles of selective photothermolysis. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device's operation. The control is described as user-driven through setting parameters and triggering the laser.
Yes
The device is used for permanent hair reduction and treatment of benign pigmented and vascular lesions, which are applications related to affecting the structure or function of the body, falling under the definition of a therapeutic device.
No
The device is an IPL + Diode Laser machine indicated for surgical and aesthetic applications such as hair reduction and treatment of benign lesions. It delivers energy for therapeutic purposes, rather than to diagnose medical conditions.
No
The device description explicitly details hardware components such as a handpiece, key switch, foot switch, control panel, main control module, constant current board module, and temperature and humidity control system, indicating it is a physical device that delivers energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device uses IPL and Diode Laser technology to directly treat the human body for procedures like hair reduction, and treatment of benign pigmented and vascular lesions. It delivers energy to the body, not analyzes samples from the body.
- Intended Use: The intended use is for surgical and aesthetic applications performed directly on the patient.
- Device Description: The description focuses on the physical components and how the light/laser energy is generated and delivered to the skin.
- Performance Studies: The performance studies mentioned are non-clinical tests verifying compliance with safety and performance standards for medical devices that interact directly with the body (like IEC 60601 series), not tests related to analyzing biological samples.
Therefore, this device falls under the category of a therapeutic or aesthetic medical device that interacts directly with the patient's body, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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 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.
Product codes
ONF, GEX
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
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.
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.
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
Not Found
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
Not Found
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:
- 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)
No clinical study is included in this submission.
Key results:
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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
1
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
2
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)
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.
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."
3
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
-
- Date of Preparation
02/28/2020
- Date of Preparation
-
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
-
- Submission Correspondent
Mr. Ray Wang
- Submission Correspondent
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
4
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
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.
5
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
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.
6
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.
7
-
- 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
-
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.
8
9. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device 1
K161286 | Predicate Device 2
K192516 | 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 Unit
Handpiece
Foot Control | Main Unit
Handpiece
Foot Control | Main Unit
Handpiece
Foot Control | SE |
| ITEM | Proposed Device | Predicate Device1
IPL Therapy Machine(K161286) | Remark | |
| Light source | Intense pulsed light | Intense pulsed light | SE | |
| Wavelength | 480-1200 nm
590-1200 nm
640-1200 nm | 480nm-1200nm
590nm-1200nm
640nm-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) | 1550 | 1230 | 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) | 1550 | 1230 | 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) | 1550 | 1230 | Analysis 1 | |
Table 7-1 General Comparison
9
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.
10
| Item | Proposed Device | Predicate Device 2
Diode Laser 808nm
K192516 | 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 | 169J/c m² | 1-70J/ cm² | Analysis 2 |400ms | 5~400ms |
| Frequency | SHR:1-10Hz
LHR:1-3 Hz | 1-20 Hz | Analysis 2 |
| | Pulse Duration | 5
| 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.
11
| Predicate Device1 | Predicate Device 2 | |||
|---|---|---|---|---|
| Item | Proposed Device | IPL Therapy | Diode Laser 808nm | Remark |
| Machine (K161286) | (K192516) | |||
| Patient Contact Materials and Biocompatibility | ||||
| Patient | ||||
| Contact | ||||
| Materials | IPL + Diode Laser | |||
| handpiece | IPL handpiece | Diode Laser handpiece | SE | |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | No Cytotoxicity | |
| Sensitization | No evidence of | |||
| sensitization | No evidence of | |||
| sensitization | No evidence of | |||
| sensitization | SE | |||
| Irritation | No evidence of | |||
| irritation | No evidence of | |||
| irritation | No evidence of | |||
| irritation | ||||
| EMC, Electrical and Laser Safety | ||||
| Electrical | ||||
| Safety | Comply with IEC | |||
| 60601-1, IEC | ||||
| 60601-2-22, | ||||
| IEC60601-2-57 | Comply with IEC | |||
| 60601-1 | Comply with IEC | |||
| 60601-1, IEC | ||||
| 60601-2-22 | SE | |||
| EMC | Comply with IEC | |||
| 60601-1-2 | Comply with IEC | |||
| 60601-1-2 | Comply with IEC | |||
| 60601-1-2 | SE | |||
| Laser Safety | Comply with | |||
| IEC 60601-2-22, | ||||
| IEC 60825 , | ||||
| IEC60601-2-57 | Comply with | |||
| IEC60601-2-57 | Comply with IEC | |||
| 60601-2-22, IEC | ||||
| 60825 | SE | |||
| Power Supply | AC110V, | |||
| 50/60Hz | AC 110V 50Hz | AC 110V/60Hz or | ||
| 250V 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.
12
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.