(52 days)
Not Found
No
The description focuses on standard laser technology and microprocessor control for basic functions. There is no mention of AI/ML terms, image processing, or data sets for training/testing.
No.
The device is intended for hair removal and permanent hair reduction, which are cosmetic procedures, not therapeutic treatments for diseases or medical conditions.
No
Explanation: The device description states its intended use is for "hair removal, permanent hair reduction," which is a treatment, not a diagnostic process. There is no mention of the device being used to identify or analyze a condition.
No
The device description clearly states it consists of a main unit and a hand piece, utilizes a diode laser, and includes a water cooling system, all of which are hardware components. The software mentioned is for controlling electronics, not the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for hair removal and permanent hair reduction. This is a cosmetic/therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a laser system that emits light to interact with hair follicles. It does not involve the examination of specimens (blood, tissue, etc.) taken from the body.
- Lack of IVD Characteristics: The description and performance studies focus on the device's safety and effectiveness for its intended use on the body, not on its ability to diagnose or provide information about a patient's health status based on in vitro analysis.
IVD devices are specifically designed to examine specimens in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This laser system does not fit that description.
N/A
Intended Use / Indications for Use
The 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 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 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.
The Laser Treatment System includes two (2) models, NYX and Grace, the differences between them are the external shape and the numbers of the handpiece connectors, NYX is the desktop type with one handpiece connector, and Grace is vertical stand type with two handpiece connectors.
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 Performance Testing:
- Biocompatibility testing: Evaluated in accordance with ISO 10993-1:2009 for "Surface –intact skin" 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.
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Image /page/0/Picture/0 description: The image contains 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 26, 2021
Canadian Pioneer Medical Technology Corporation Dr. Rashid Reza Mir Savah Managing Director Unit 2, 210 Drumlin Circle Concord, Vaughan, Ontario L4K 3E3 CAN
Re: K210033
Trade/Device Name: Laser Treatment System, Model: NYX and Grace 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: December 24, 2020 Received: January 5, 2021
Dear Dr. Rashid Reza Mir Sayah:
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.
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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 and Part 809); 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 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
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Indications for Use
510(k) Number (if known) K210033
Device Name
Laser Treatment System, Model: NYX and Grace
Indications for Use (Describe)
The 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) |
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510(k) Summary: K210033
l. Submitter
Canadian Pioneer Medical Technology Corporation Unit 2-210 Drumlin Circle, Vaughan, Ontario, L4K 3E3, Canada
Contact person: Dr. Rashid Reza Mir Sayah Managing Director Phone: 4377727788 Email: Canadianpioneer@yahoo.com Canadianpioneer@gmail.com Info@Canadianlasers.com Date of preparation: Feb.20th, 2021
II. Subject Device
Trade Name of Device: Laser Treatment System, Model: NYX and Grace Common name: Powered Laser Surgical Instrument Classification Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology 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 Treatment System Manufacturer: Weifang KM Electronics Co., LTD" Common name: Powered Laser Surgical Instrument Requlation Number: 21 CFR 878.4810 Requlatory Class: II Product code: GEX Review Panel: General & Plastic Surgery 510(k) number: K182924
IV. Device description
The 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
4
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 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.
The Laser Treatment System includes two (2) models, NYX and Grace, the differences between them are the external shape and the numbers of the handpiece connectors, NYX is the desktop type with one handpiece connector, and Grace is vertical stand type with two handpiece connectors.
V. Indications for use
The 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 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 differences between the subject device and predicate devices do not alter suitability of the proposed device for its intended use.
| Device feature | Laser Treatment System, Model:
NYX and Grace (K210033) | Diode Laser Treatment System
(K182924) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Canadian Pioneer Medical
Technology Corporation | Weifang KM Electronics Co., Ltd. |
| Product code | GEX | GEX |
| Regulation
number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Indications for
use | The 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 | 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 |
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| regime. | 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. | ||
| Laser type | Diode laser | Diode laser |
| Laser classification | Class IV | Class IV |
| Laser wavelength | 808nm | 808nm |
| Spot Size | 1.44 cm² | 1.44 cm² |
| Fluence | 1-120J/cm² | 2-120J/cm² |
| Frequency | 1-10Hz | 1-10Hz |
| Pulse Duration | 10-300ms | 10-300ms |
| Power supply | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz |
| Patient contact material | Sapphire in handpiece and | |
| handpiece tip (stainless steel) | Sapphire in handpiece and | |
| handpiece tip (stainless steel) | ||
| Biocompatibility | Comply with ISO10993-1 | Comply with ISO10993-1 |
| Electrical Safety | Comply with IEC60601-1, | |
| IEC60601-2-22 | Comply with IEC60601-1, | |
| IEC60601-2-22 | ||
| EMC | Comply with IEC 60601-1-2, | Comply with IEC60601-1-2, |
| Laser safety | Comply with IEC60825-1, | |
| IEC60601-2-22 | Comply with IEC60825-1, | |
| IEC60601-2-22 |
VII Summary of Non-clinical Performance Testing
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 –intact skin" with a contact duration of "Limited (