(178 days)
Not Found
No
The description mentions a microprocessor for controlling electronics and preset working modes, but there is no indication of adaptive learning, pattern recognition, or other AI/ML characteristics. The device operates based on fixed parameters for each mode.
No.
Therapeutic devices are used to treat illnesses or injuries. This device is for hair removal and permanent hair reduction.
No
Diagnosis involves identifying a disease or condition, which this device does not do; it provides treatment (hair removal and reduction).
No
The device description explicitly states it consists of a "main unit and a hand piece" and uses a "diode laser as an active medium," indicating it is a hardware-based device with software controlling its operation, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The Diode Laser Treatment System is a device that uses a laser to directly interact with the human body for hair removal. It does not analyze samples taken from the body.
- Intended Use: The intended use is for hair removal and permanent hair reduction, which is a physical treatment applied to the body, not a diagnostic test performed on a sample.
Therefore, based on the provided information, this device falls under the category of a therapeutic or aesthetic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Diode Laser Treatment 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.
Product codes
GEX
Device Description
The Diode Laser Treatment System consists of the main unit and a hand piece. The system uses a diode laser as an active medium placed in an optical cavity to produce amplified beam at the wavelength of 808 nm. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit.
The device provides 36 working modes, which are six modes for men and six modes for women. The men or women mode includes face, armpit, arm, body, bikini, leg mode respectively for different treatment part. The diode laser operates in a pulsed mode with a fixed pulse width and fixed pulse duration of the pulse train for each mode. The number of pulses can be adjusted within the preset range.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
face, armpit, arm, body, bikini, leg
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Laser Treatment System was evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (
§ 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 contains the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Weifang KM Electronics Co., LTD Andy Pang General Manager No. 7999 Health East Street, High-tech District Weifang, 261000 CN
April 15, 2019
Re: K182924
Trade/Device Name: Diode Laser Treatment 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: March 11, 2019 Received: March 13, 2019
Dear Andy Pang:
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.
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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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,
| Neil R | Digitally signed by Neil | |
|---|---|---|
| Ogden -S | R Ogden -S | |
| Date: 2019.04.15 | ||
| 09:23:59 -04'00' | ||
| 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
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Section 4 Indications for use
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Diode Laser Treatment System
Indications for Use (Describe)
The Diode Laser Treatment 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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Section 5 510(k) summary
l Submitter
Device submitter: Weifang KM Electronics Co., Ltd.
No.7999 Health East Street, High-tech District, Weifang City, Shandong, China
Contact person: Andy PANG General Manager Phone: +86 136 0646 4486 Fax: +86-536-8885351 Email: 51050359@qq.com Date of preparation: Oct 12th, 2018
II Device
Trade Name of Device: Diode Laser Treatment System Models: KM200D, KM300D, KM600D, KM800D, KM900D Common name: Powered Laser Surgical Instrument Regulation Number: 21 CFR 878.4810 Regulatory Class: II Product code: GEX Review Panel: General & Plastic Surgery
III Predicate Devices
Trade Name of Device: Diode Laser Therapy Machine Common name: Powered Laser Surgical Instrument Regulation Number: 21 CFR 878.4810 Requlatory Class: II Product code: GEX Review Panel: General & Plastic Surgery 510(k) number: K161692
Trade Name of Device: Diode Laser Hair Removal System Common name: Powered Laser Surgical Instrument Regulation Number: 21 CFR 878.4810 Regulatory Class: II Product code: GEX Review Panel: General & Plastic Surgery 510(k) number: K141973
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IV Device description
The Diode Laser Treatment System consists of the main unit and a hand piece. The system uses a diode laser as an active medium placed in an optical cavity to produce amplified beam at the wavelength of 808 nm. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit.
The device provides 36 working modes, which are six modes for men and six modes for women. The men or women mode includes face, armpit, arm, body, bikini, leg mode respectively for different treatment part. The diode laser operates in a pulsed mode with a fixed pulse width and fixed pulse duration of the pulse train for each mode. The number of pulses can be adjusted within the preset range.
V Indications for use
The Diode Laser Treatment 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.
VI Comparison of technological characteristics with the predicate devices
The Diode Laser Treatment System has the same technological characteristics and fundamental design as the predicate device. The subject device and the predicate devices are all designed for hair removal on different parts of the body. The differences between the subject device and predicate devices do not alter suitability of the proposed device for its intended use.
| Device feature | Diode Laser Treatment System (subject device) | Diode Laser Therapy Machine FG 2000-B K161692 | Diode Laser Hair Removal System K141973 |
|---|---|---|---|
| Product code | GEX | GEX | GEX |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Indications for use | The Diode Laser Treatment System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin | The Diode Laser Therapy Machine is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin | The Diode Laser Hair Removal System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin |
| type I-VI), including | type I-VI), including | type I-VI), including | |
| tanned skin. | tanned skin. | 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. | 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. | 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. | |||
| Operation principle | Melanin could absorb | ||
| the energy from the | |||
| laser, which would result | |||
| in temperature rapid | |||
| increase, to destroy | |||
| surrounding hair | |||
| follicles, and finally | |||
| remove hair. | Melanin could absorb | ||
| the energy from the | |||
| laser, which would result | |||
| in temperature rapid | |||
| increase, to destroy | |||
| surrounding hair follicles, | |||
| and finally remove hair. | Melanin could absorb | ||
| the energy from the | |||
| laser, which would result | |||
| in temperature rapid | |||
| increase, to destroy | |||
| surrounding hair | |||
| follicles, and finally | |||
| remove hair. | |||
| Laser type | Diode laser | Diode laser | Diode laser |
| Laser classification | Class IV | Class IV | Class IV |
| Laser wavelength | 808nm | 808nm | 808nm |
| Spot Size | 1.44 cm² | 1.44 cm² | 1.44 cm² |
| Fluence | 2-120J/cm² | 2-120J/cm² | 1-120J/cm² |
| Frequency | 1-10Hz | 1-10Hz | 1Hz, 2Hz, 3Hz, 10Hz |
| Pulse Duration | 10-300ms | 9-143ms | 2.9-348ms |
| Power supply | 100-240V AC, 50/60Hz | AC110V/50-60Hz | AC110V, 60Hz |
| Dimension | KM200D 604238cm | ||
| KM300D 604235cm | |||
| KM600D 604235cm | |||
| KM800D 604240cm | |||
| KM900D 554230cm | 426354cm | 3854120cm | |
| Weight | 35kg | 30kg | 55kg |
| Patient contact | |||
| material | Sapphire in handpiece | ||
| and handpiece tip | |||
| (stainless steel) | Sapphire in handpiece | ||
| and handpiece tip | |||
| (stainless steel) | Sapphire in handpiece | ||
| and handpiece tip | |||
| (stainless steel) | |||
| Biocompatibility | Comply with | Comply with | Comply with |
5
6
| Electrical
Safety | Comply
IEC60601-1,
IEC60601-2-22 | with | Comply
IEC60601-1,
IEC60601-2-22 | with | Comply
IEC60601-1,
IEC60601-2-22 | with |
|----------------------|----------------------------------------|------|----------------------------------------|------|----------------------------------------|------|
| EMC | Comply
IEC60601-1-2, | with | Comply
IEC60601-1-2, | with | Comply
IEC60601-1-2, | with |
| Laser safety | Comply
IEC60825-1,
IEC60601-2-22 | with | Comply
IEC60825-1,
IEC60601-2-22 | with | Comply
IEC60825-1,
IEC60601-2-22 | with |
VII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Laser Treatment System was evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (