(68 days)
Not Found
No
The device description details standard microcontroller-based control systems and sensor feedback loops, without mentioning any AI/ML components or algorithms. The performance studies focus on safety and basic performance metrics, not AI/ML performance.
No.
Explanation: The "Intended Use" states the device is for "hair reduction" and "permanent hair reduction," which are cosmetic purposes rather than treating a disease or injury. While the device description mentions it being a "surgical device" and the performance studies refer to a standard for "Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment," the primary stated intention is cosmetic hair reduction.
No
The device is described as a "surgical device" intended for "hair removal" and "permanent hair reduction," which are therapeutic/cosmetic functions, not diagnostic ones. Although it has detection functions for operating parameters (temperature, humidity, over-current, etc.), these are for ensuring the proper and safe operation of the device, not for diagnosing a patient's condition.
No
The device description clearly outlines multiple hardware components including a control panel with an LCD screen, a main control module with sensors, a constant current board module, a temperature and humidity control system with a condenser and fans, and a handpiece module containing a semiconductor laser and cooling components. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "hair reduction on all skin types". This is a physical treatment applied to the body, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a laser system designed to emit light for hair removal. It describes components related to controlling and delivering laser energy, cooling, and safety features. None of these components are related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or diagnostic results.
The device is clearly described as a surgical device intended for a cosmetic/therapeutic procedure (hair removal).
N/A
Intended Use / Indications for Use
The Diode Laser Hair Removal device 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
GEX
Device Description
The proposed device, Diode Laser Hair Removal device, 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. 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 laser energy by the operator.
b. Main Control Module
The module uses the microcontroller as the heart, receives the 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 laser energy parameters from the main control module, supplies the semiconductor laser with constant drive current which corresponding to the received laser energy parameters to drive the semiconductor laser to emit light. The module also has the detection function of over-current, overvoltage, 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 semiconductor laser working.
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 module is mainly composed of semiconductor laser, sapphire, temperature and humidity sensor, data storage chips, cooling components and water flow path. The semiconductor 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 semiconductor laser to prevent it from being damaged caused by over-temperature, so prolongs the service life of the semiconductor laser.
Mentions image processing
No
Mentions AI, DNN, or ML
No
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
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.
- 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)
- Performance Testing for Spot Size Accuracy and Energy Output Accuracy.
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 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 17, 2018
Zhengzhou PZ Laser Slim Technology Co., Ltd Mr. 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: K180353
Trade/Device Name: Diode laser hair removal device 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: February 6, 2018 Received: February 8, 2018
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 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
1
801); medical device reporting of medical device-related 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer R. Stevenson -S3
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
Indications for Use
510(k) Number (if known) K180353
Device Name Diode laser hair removal device
Indications for Use (Describe)
The Diode Laser Hair Removal device 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
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: K180353
-
- Date of Preparation
04/13/2018
- Date of Preparation
-
- Sponsor
Zhengzhou PZ Laser Slim Technology Co., Ltd
Fl 2th, jia Tu zhi ye, intersection of Hong Song road and lian Hua road, High-tech Development Zone, 450001, Zhengzhou City, Henan Province, China
Establishment Registration Number: Not yet registered Contact Person: Zhou Hongwei Position: General Manager Tel: +86-18736013788 Fax: +86-371-55677886 Email: 565107678@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: +86-10-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com
4
4. Identification of Proposed Device
Trade Name: Diode laser hair removal device Common Name: Powered Laser Surgical Instrument Model(s): PZ-806NVA
Regulatory Information: Classification Name: Powered Laser Surgical Instrument Classification: II; Product Code: GEX ; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;
Intended Use:
The Diode Laser Hair Removal device 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 Hair Removal device, 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. 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 laser energy by the operator.
b. Main Control Module
The module uses the microcontroller as the heart, receives the 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
5
The module uses the high-power MOS as the heart, receives the laser energy parameters from the main control module, supplies the semiconductor laser with constant drive current which corresponding to the received laser energy parameters to drive the semiconductor laser to emit light. The module also has the detection function of over-current, overvoltage, 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 semiconductor laser working.
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 module is mainly composed of semiconductor laser, sapphire, temperature and humidity sensor, data storage chips, cooling components and water flow path. The semiconductor 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 semiconductor laser to prevent it from being damaged caused by over-temperature, so prolongs the service life of the semiconductor laser.
6
-
- Identification of Predicate Device
510(k) Number: K162659 Product Name: Diode Laser Hair Removal System Manufacturer: Shandong Huamei Technology Co.,ltd.
- Identification of Predicate Device
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:
-
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.
-
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)
-
Performance Testing for Spot Size Accuracy and Energy Output Accuracy.
- Clinical Test Conclusion 8.
No clinical study is included in this submission.
7
9. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| K162659 | |||
| Product Code | GEX | GEX | SE |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Intended Use | The Diode Laser Hair Removal | ||
| device 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. | SE | ||
| Configuration | Main Unit | Main Unit | SE |
| Handpiece | Handpiece | SE | |
| Foot Control | Foot Control | SE | |
| Principle of | |||
| Operation | Diode Laser | Diode Laser | SE |
Table 7-1 General Comparison
8
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| K162659 | |||
| Laser Type | Diode Laser | Diode Laser | SE |
| Laser Classification | Class IV | Class IV | SE |
| Laser Wavelength | 808 nm | 808 nm | SE |
| Spot Size | 1.44 cm2 | 1.44 cm2 | SE |
| Fluence | 1-100J/cm2 | 1-120J/cm2 | Discussion |
| Irradiance | 14-360 W/cm2 | 347.8 W/cm2 | Discussion |
| Frequency | 1-20 Hz | 0.5-15Hz | Discussion |
| Pulse Duration | 10-400ms | 5-400ms | Discussion |
| Power Supply | AC 110V-230V/50-60Hz | ||
| 2000VA | AC 110V/60Hz | SE | |
| Dimension | 560mmx380mmx1180mm | 450mm× 550mm×380mm | Discussion |
| Weight | 60Kg | 52Kg | Discussion |
Table 7-2 Performance Comparison
Discussion
The proposed device is different in fluence, frequency range, pulse duration, dimension and weight from the predicate device. By complying with non-clinical test conducted, the proposed device is determined to be substantially equivalency with predicate device.
9
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| K162659 | |||
| Patient Contact Materials and Biocompatibility | |||
| Patient Contact | |||
| Materials | Sapphire in handpiece | Sapphire in handpiece | SE |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | |
| Sensitization | No evidence of sensitization | No evidence of sensitization | SE |
| 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 | SE | ||
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Laser Safety | Comply with IEC 60601-2-22, | ||
| IEC 60825 | Comply with IEC 60601-2-22, | ||
| IEC 60825 | SE |
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.