(86 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on standard laser system components.
No.
The device's stated intended use is for hair reduction, which is a cosmetic purpose and not a therapeutic one aimed at treating a disease or condition. One of the standards it complies with is for "Cosmetic" laser equipment.
No
The device description, intended use, and indications for use all state that the Diode Laser Therapy System is intended for hair reduction/removal, which is a therapeutic or cosmetic purpose, not a diagnostic one.
No
The device description explicitly lists hardware components such as a power system, microprocessor control system, cooling system, and handpiece module, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "hair reduction on all skin types". This is a therapeutic/cosmetic procedure performed directly on the patient's body.
- Device Description: The device is described as a "surgical device" intended for "hair removal, permanent hair reduction". This aligns with a device used for treatment, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in vitro (outside the body), or providing diagnostic information about a patient's health condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Diode Laser Therapy System is intended for 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 (comma separated list FDA assigned to the subject device)
GEX
Device Description
The proposed device, Diode Laser, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
Function module description
a. Power System
Power system including network power supply, laser power supply system, refrigeration power supply system and auxiliary power supply system, as shown in Fig 9-1.
The power lines and rocker switch are used to control the on -off of hair removal instrument with the outside power supply. The key switch, emergency stop switch are used to control the on-off of network power, and then through the auxiliary power supply, provide the work current for the microprocessor control system, touch screen operation display system and other functional components, meanwhile, the on-off of power system for refrigeration and laser are realized by the pick-up and switching off of the relay that controlled by micro - processor. The power-on, energizing and the light emission process of main unit are subject to microprocessor control, in order to achieve controlling the hardware with software through microprocessor, so that the appliance operation are more stable and reliable.
Laser power system adopt the power devices to constitute current regulation loop, thus can change the volume of output current through system regulation power devices of microprocessor, thereby controlling the volume of output laser energy and work pulse width, through the feedback loop, export the current sampling signal and send to the micro - processor for real-time monitoring.
Various power supply components from the power system of laser hair removal instrument mostly adopt the safe and reliable switching power supply to achieve AC-DC conversion, these components passed through CE- certification, so that the safe effectiveness of the system get adequately guarantee, not only ensure the personal safety of users, but also ensures the long-term and reliable work of the devices itself.
The power system has the perfect self-protection function, it can continuously feed a number of important signal back to the microprocessor, once the important signal has an error, the microprocessor will promptly notify the users through the friendly man-appliance interface (Touch Screen) and take automatic protection treatment .After the error sigmal is released, the power system can automatically return to normal state.
b. Microprocessor Control System
Diode Laser device adopt the microprocessor control system. The microprocessor control system is composed of microprocessor, control loop and detection circuit, see Fig 9-1.
Control module of hair removal instrument is highly automated, the user just needs to turn on rocker switch and key switch and eject emergency stop switch, after power-on, the system will automatically perform the self-check for the control system (include all the preset checks against some possible damages to the appliance and the calling of treatment parameters and other a series of actions.
c. Operation Display System
Operation Display System is composed of touch screen, indicator and buzzer.
Among them, the touch screen connect directly to the host microprocessor, the operator can operate the touch screen to control the microprocessor to work, and through the information that is displayed on the screen to understand the main unit state and the relevant parameters, the hair removal instrument adopt the safe and reliable touch screen that passed through CE certification, also, the manufacturer designed a simple and intuitive operational interface, which can be easy to realize man-machine dialogue.
The indicators are used to display the work state of main unit; meanwhile, the buzzer is used as the prompt for laser output and fault alarm.
d. Cooling System
Cooling system consists of cooling fan, cooling water re-circulation system and water temperature regulation system.
After the laser hair removal instrument starting, the cooling system begins to work and adjust the water temperature to the preset temperature scale. The cooling fan give air cooling for the electric parts and radiator in the main unit, through air flow in the appliance to take away the generated heat.
When the laser is running, internal circulating water can displace and takes away the heat and deliver to the water temperature regulation system, where the heat can be displaced and sent to the radiator for dispersion. Therefore, the circulation water temperature is maintained within a dynamic balance range, this ensures the normal working temperature of laser. By monitoring cooling water temperature in real time through temperature sampling, the control system can start the cooling components from the water temperature regulation system in due time to adjust water temperature, also, it can automatically judges whether the temperature is normal. If the temperature exceeds the early warning value that preset, the system will automatically disable laser output and give alarm so as to avoid damage to the laser.
e. Handpiece module
Handpiece module is the heart of the device, which is the execution unit of the device and completes the laser emission function. The semiconductor laser emits light to output energy.
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:
- AAMI/ANIS/ES 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.
- IEC 60601-1-2:2014 , Medical electrical equipment - Part 1-2: General requirements for basic 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 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.
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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 13, 2019
San He Lefis Electronics 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: K192569
Trade/Device Name: Diode Laser Therapy System 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: GEX Dated: September 16, 2019 Received: September 18, 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
1
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 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 (QS) 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,
Purva Pandya 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
Indications for Use
510(k) Number (if known)
Device Name Diode Laser Therapy System
Indications for Use (Describe)
The Diode Laser Therapy System is intended for 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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: K 1 9 2 5 6 9
-
Date of Preparation 1.
09/16/2019 -
Sponsor 2.
San He Lefis Electronics Co., Ltd.
No. 1 Production Room., ChaoBai Street, West Yiangbin Road, YanJiao Development Zone, Sanhe County, LangFang, HeBei Province, China 300000
Contact Person: Position: Ning Li Title: General Manager Assistant Tel: +86-18811392951 Fax: +86-316-3096027 Email: 1091118421@qq.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: Diode Laser Therapy System Common Name: Powered Laser Surgical Instrument Model(s): LFS-K8
Regulatory Information: Classification Name: Powered Laser Surgical Instrument Classification: II; Product Code: GEX ; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;
Indication For Use:
The Diode Laser Therapy System 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.
5. Device Description
The proposed device, Diode Laser, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
Function module description
a. Power System
Power system including network power supply, laser power supply system, refrigeration power supply system and auxiliary power supply system, as shown in Fig 9-1.
The power lines and rocker switch are used to control the on -off of hair removal instrument with the outside power supply. The key switch, emergency stop switch are used to control the on-off of network power, and then through the auxiliary power supply, provide the work current for the microprocessor control system, touch screen operation display system and other functional components, meanwhile, the on-off of power system for refrigeration and laser are realized by the pick-up and switching off of the relay that controlled by micro - processor. The power-on, energizing and the light emission process of main unit are subject to microprocessor control, in order to achieve controlling the hardware with software through microprocessor, so that the appliance operation are more stable and reliable.
Laser power system adopt the power devices to constitute current regulation loop, thus can change the volume of output current through system regulation power devices of microprocessor, thereby
5
controlling the volume of output laser energy and work pulse width, through the feedback loop, export the current sampling signal and send to the micro - processor for real-time monitoring.
Various power supply components from the power system of laser hair removal instrument mostly adopt the safe and reliable switching power supply to achieve AC-DC conversion, these components passed through CE- certification, so that the safe effectiveness of the system get adequately guarantee, not only ensure the personal safety of users, but also ensures the long-term and reliable work of the devices itself.
The power system has the perfect self-protection function, it can continuously feed a number of important signal back to the microprocessor, once the important signal has an error, the microprocessor will promptly notify the users through the friendly man-appliance interface (Touch Screen) and take automatic protection treatment .After the error sigmal is released, the power system can automatically return to normal state.
b. Microprocessor Control System
Diode Laser device adopt the microprocessor control system. The microprocessor control system is composed of microprocessor, control loop and detection circuit, see Fig 9-1.
Control module of hair removal instrument is highly automated, the user just needs to turn on rocker switch and key switch and eject emergency stop switch, after power-on, the system will automatically perform the self-check for the control system (include all the preset checks against some possible damages to the appliance and the calling of treatment parameters and other a series of actions.
c. Operation Display System
Operation Display System is composed of touch screen, indicator and buzzer.
Among them, the touch screen connect directly to the host microprocessor, the operator can operate the touch screen to control the microprocessor to work, and through the information that is displayed on the screen to understand the main unit state and the relevant parameters, the hair removal instrument adopt the safe and reliable touch screen that passed through CE certification, also, the manufacturer designed a simple and intuitive operational interface, which can be easy to realize man-machine dialogue.
The indicators are used to display the work state of main unit; meanwhile, the buzzer is used as the prompt for laser output and fault alarm.
d. Cooling System
Cooling system consists of cooling fan, cooling water re-circulation system and water temperature regulation system.
After the laser hair removal instrument starting, the cooling system begins to work and adjust the water temperature to the preset temperature scale. The cooling fan give air cooling for the electric
6
parts and radiator in the main unit, through air flow in the appliance to take away the generated heat.
When the laser is running, internal circulating water can displace and takes away the heat and deliver to the water temperature regulation system, where the heat can be displaced and sent to the radiator for dispersion. Therefore, the circulation water temperature is maintained within a dynamic balance range, this ensures the normal working temperature of laser. By monitoring cooling water temperature in real time through temperature sampling, the control system can start the cooling components from the water temperature regulation system in due time to adjust water temperature, also, it can automatically judges whether the temperature is normal. If the temperature exceeds the early warning value that preset, the system will automatically disable laser output and give alarm so as to avoid damage to the laser.
e. Handpiece module
Handpiece module is the heart of the device, which is the execution unit of the device and completes the laser emission function. The semiconductor laser emits light to output energy.
7
-
- Identification of Predicate Device and Reference Device
Primary Predicate Device 510(k) Number: K181019 Product Name: Diode Laser System Manufacturer: Guangzhou Huafei Tongda Technology Co., Ltd.
- Identification of Predicate Device and Reference Device
Reference Device 510(k) Number: K162659 Product Name: Diode Laser Hair Removal System Manufacturer: Shandong Huamei Technology Co.,ltd.
-
- 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
-
AAMI/ANIS/ES 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.
-
IEC 60601-1-2:2014 , Medical electrical equipment - Part 1-2: General requirements for basic 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
No clinical study is included in this submission.
8
9. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device | Reference Device | Remark |
|---|---|---|---|---|
| Product Code | GEX | K181019 | K162659 | SE |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Intended Use | The Diode Laser Therapy System 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 Diode Laser System 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 Diode Laser Hair Removal System 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 | |||
| Principle of Operation | Diode Laser | Diode Laser | Diode Laser | SE |
Table 7-1 General Comparison
9
| Item | Proposed Device | Predicate Device
K181019 | Reference Device
K162659 | Remark |
|----------------------|-----------------------|-----------------------------|-----------------------------|------------|
| Laser Type | Diode Laser | Diode Laser | Diode Laser | SAME |
| Laser Classification | Class IV | Class IV | Class IV | SAME |
| Laser Wavelength | 808 nm | 808 nm | 808 nm | SAME |
| Spot Size | $2.80\text{cm}^2$ | $1.20\text{cm}^2$ | $1.44 \text{ cm}^2$ | Discussion |
| Pulse Duration | 3ms-400ms | 30ms-200ms | 5-400ms | Discussion |
| Fluence | 2-40 J/ $\text{cm}^2$ | 5-40 J/ $\text{cm}^2$ | 1-120J/ $\text{ cm}^2$ | SAME |
| Frequency | 1-10Hz | 1-5Hz | 0.5-15Hz | Discussion |
| Power Supply | 110V50/60Hz | 100-240V 50/60Hz | AC 110V/60Hz | Discussion |
| Dimension | 510mm×600mm× | 510mm×600mm× | 450mm× | Discussion |
| | 1000mm | 1000mm | 550mm×380mm | |
| Weight | 45Kg | 50Kg | 52Kg | Discussion |
Table 7-2 Performance Comparison
Discussion
The proposed device has same indication for use with predicate devices, the main differences are output parameters, such as spot size, frequency range, pulse duration.
For these output parameters, the Fluence and Pulse duration are most important parameters which may decides that how much and how long time the energy will deliver to the patient's skin, it may effects the safety (too much energy and/or too long action time) may burn patient's skin, and effectiveness (too low energy and/or too short action time) may make the device could not achieve it's indication for use.
From the comparison above, the fluence of proposed device is 5-40 J/cm2, the fluence of predicate device are 5-40 J/cm2. They are exactly same, that's means the proposed device has capable to achieve it's indication for use.
The Pulse duration of proposed device is 3 ms -400 ms, which is difference with the predicate device, but which is same with the reference device (K162659), since the reference device has more longer fluence (120 J/cm2), then the 400 ms maximum pulse with 40 J/cm2 of proposed device could be consider as safety.
For the other differences (Spot Size, Frequency, Power Supply, Dimension and Weight), they would not affects the safety and effectiveness of proposed device for it's indications for use. And 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
K162659 | Reference Device
K162659 | Remark |
|------------------------------------------------|-----------------------------------------|-----------------------------------------|-----------------------------------------|--------|
| Patient Contact Materials and Biocompatibility | | | | |
| Patient Contact
Materials | Handpiece tip | Handpiece tip | Handpiece tip | SAME |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | No Cytotoxicity | |
| Sensitization | No evidence of sensitization | No evidence of sensitization | No evidence of sensitization | SAME |
| 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 | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | SAME |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | Comply with IEC 60601-2-22, IEC 60825 | SAME |
Table 7-3 Safety Comparison
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.