(263 days)
Not Found
No
The device description details standard microcontroller-based control systems and sensor feedback loops, without mentioning any AI or ML algorithms or functionalities.
No
The device is intended for hair reduction, which is a cosmetic purpose, not a therapeutic one. The device description also classifies it as a "surgical device" rather than a therapeutic one further supporting this.
No
The device is a Diode Laser System intended for hair reduction and permanent hair reduction. Its listed functions involve controlling laser energy output and monitoring internal system parameters, not diagnosing medical conditions or diseases.
No
The device description clearly outlines multiple hardware components including a control panel, main control module, constant current board module, temperature and humidity control system, and a handpiece module containing a semiconductor laser, sapphire, sensors, and cooling components. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "hair reduction on all skin types". This is a physical treatment applied to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device 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. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a therapeutic device used for a cosmetic/medical procedure (hair reduction).
N/A
Intended Use / Indications for Use
The Diode Laser 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 Hair Removal System, 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
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 60601-2-2:2007, 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: 2007, Safety of laser products - Part 1: Equipment classification and requirements.
- IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
- ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
- ISO 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1
- 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): 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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 16, 2017
Shandong Huamei Technology Co.,ltd. % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, Dafangju, No.25 Banbidian Rd. Liyuan Town, Tongzhou District, Beijing Beijing, 101121 CN
Re: K162659
Trade/Device Name: Diode Laser Hair Removal 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: October 13, 2016 Received: October 17, 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. Isting 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
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
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)
Device Name
Diode Laser System
Indications for Use (Describe)
The Diode Laser 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.
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 Druq 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."
Type of Use (Select one or both, as applicable)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
EF
PSC Publishing Services (301) 443-6740
3
Tab #5 510(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: K162659
-
- Date of Preparation
05/19/2017
- Date of Preparation
-
Sponsor 2.
Shandong Huamei Technology Co., Ltd.
588, Changning Street, High-tech District, WeiFang, ShanDong, China, 261000
Establishment Registration Number: Not yet registered or the Number Contact Person: Xu QingHua Position: General Manager Tel: 86-536-2110001 Fax: 86-536-2109823 Email: xuqh@yeah.net
- Submission Correspondent 3.
Mr. Ray Wang
Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China
Tel: +86-10-18910677558 Fax: +86-10-52214696 Email: ray.wang@believe-med.com
4
4. Identification of Proposed Device
Trade Name: Diode Laser Hair Removal System Common Name: Powered Laser Surgical Instrument Model(s): HM-DL100
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 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 Hair Removal System, 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
Predicate 1# 510(k) Number: K141973 Product Name: Diode Laser Hair Removal System Manufacturer: Beijing Anchorfree Technology Co., Ltd
- Identification of Predicate Device
Predicate 2# 510(k) Number: K123483 Product Name: Diode Laser Manufacturer: Beijing Syntech Laser 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
-
IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
-
IEC 60601-2-2:2007, 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: 2007, Safety of laser products - Part 1: Equipment classification and requirements.
-
IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
-
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
-
ISO 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1
-
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 | Predicate Device | Remark |
|---|---|---|---|---|
| K141973 | K123483 | |||
| Product Code | GEX | GEX | GEX | SE |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Intended Use | 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. | The Diode Laser is intended | |||
| for use in dermatologic and | ||||
| general surgical procedures. |
The Standard Mode is
intended for hair removal,
permanent hair reduction.
The FHR Mode is intended
for hair removal, permanent
hair reduction.
The diode laser system is
intended for use on all skin
types (Fitzpatrick skin types
I-VI), including tanned skin. | SE |
| Configuration | Main Unit | Main Unit | Main Unit | SE |
| | Handpiece | Handpiece | Handpiece | SE |
| | Foot Control | Foot Control | Foot Control | SE |
| Principle of
Operation | Diode Laser | Diode Laser | Diode Laser | SE |
Table 1 General Comparison
8
| Item | Proposed Device | Predicate Device | Predicate Device | Remark |
|---|---|---|---|---|
| K141973 | K123483 | |||
| Laser Type | Diode Laser | Diode Laser | Diode Laser | SE |
| Laser Classification | Class IV | Class IV | Class IV | SE |
| Laser Wavelength | 808 nm | 808 nm | 808 nm | SE |
| Spot Size | 1.44 cm2 | 1.44 cm2 | 1.2 cm2 | SE |
| Fluence | 1-120J/ cm2 | 1-120 J/cm2 | 1-120 J/cm2 | SE |
| Irradiance | 0.7-347.8 W/cm2 | 347.2 W/cm2 | 600 W/cm2 | SE |
| Frequency | 0.5-15Hz | 1Hz, 2Hz, 3Hz, 10Hz | ≤10 Hz | Discussion |
| Pulse Duration | 5-400ms | 2.9-348ms | 5-200 ms | Discussion |
| Power Supply | AC 110V/60Hz | AC220V, 50Hz/ AC110V, | ||
| 60Hz | 100-240 V 50/60Hz | SE | ||
| Dimension | 450mm× 550mm×380mm | 380mm×540mm×1200mm | 460X 365 X350 mm | Discussion |
| Weight | 52 | 55kg | 25 kg | Discussion |
Table 2 Performance Comparison
Discussion
The proposed device is different in 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 |
|---|---|---|---|
| K141973, K123483 | |||
| Patient Contact Materials and Biocompatibility | |||
| Patient Contact | |||
| Materials | Sapphire in handpiece | Sapphire in handpiece | SE |
| Cytotoxicity | No Cytotoxicity | Comply with ISO 10993-1 | |
| Sensitization | No evidence of sensitization | SE | |
| Irritation | No evidence of irritation | SE | |
| 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 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.