(266 days)
Not Found
No
The description mentions a microprocessor for control but does not include any terms or descriptions related to AI, ML, or the processing of complex data like images for analysis or decision-making. The performance studies focus on safety and biocompatibility, not algorithmic performance.
Yes
The device is intended for the "removal of benign vascular lesions and vascular dependent lesions," which is a therapeutic purpose.
No
The device is intended for treatment (removal of lesions) using laser technology, not for diagnosing conditions.
No
The device description clearly outlines a physical system including a main unit, handpieces, laser components, a microprocessor for control, and a water cooling system. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided text clearly describes a Laser Treatment System used for dermatology procedures requiring coagulation and specifically for the treatment of benign vascular and vascular dependent lesions. This is a therapeutic device that acts directly on the patient's body, not on specimens taken from the body.
- Lack of IVD Characteristics: The description does not mention any collection, preparation, or analysis of biological specimens. It focuses on the laser technology and its application to the skin.
Therefore, based on the provided information, this device is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis, when used with the simultaneous triple wavelength module 755-808-1064 nm, is intended for : · Benign vascular lesions and vascular dependent lesions removal
Product codes
GEX
Device Description
The Laser Treatment System consists of the main unit and its handpieces. The system uses laser as an active medium placed in an optical cavity to produce amplified beam at the applicators and the Simultaneous triple-wavelength of 755,808 and 1064 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 Laser Treatment System is designed to be used dermatology procedures requiring coagulation. The indications for use for the 3 simultaneously wavelength 755,808,1064 nm Laser Module is treatment of benign vascular and vascular dependent lesions.
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)
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 (
§ 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 and 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 25, 2022
Canadian Pioneer Medical Technology Corporation Rashid Reza Mir Sayah Unit 2 -210 Drumlin Circle, Concord Vaughan, Ontario L4K 3E3 Canada
Re: K211722
Trade/Device Name: Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis 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: January 17, 2022 Received: January 19, 2022
Dear Rashid Reza Mir:
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.
1
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 mediation-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) K211722
Device Name
Laser Treatment System Models: Nyx Plus, Grace Plus, Ares, Nemesis
Indications for Use (Describe)
The Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis, when used with the simultaneous triple wavelength module 755-808-1064 nm, is intended for :
· Benign vascular lesions and vascular dependent lesions removal
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
I Submitter
Canadian Pioneer Medical Technology Corporation 210 Drumlin Circle #2 , Vaughan, Ontario, L4K 3E3, Canada
Contact person: Dr. Rashid Reza Mir Sayah Managing Director Phone: 4377727788 Email: Canadianpioneer@yahoo.com Date of preparation: May 29, 2021
II Subject Device
Trade Name of Device: Laser Treatment System, Model: Nyx Plus , Grace Plus, Ares .Nemesis 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 Device
Trade Name of Device: Modified Alma Lasers Soprano XLTM Family of Multi-Application and Multi-Technology Platforms [SopranoXL. SopranoXLi, Soprano ICE and Soprano ICE Platinum] with Trio Diode Laser Module 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: K172193
IV Device description
The Laser Treatment System consists of the main unit and its handpieces. The system uses laser as an active medium placed in an optical cavity to produce amplified beam at the applicators and the Simultaneous triple-wavelength of 755,808 and 1064 nm. A
4
microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit. The Laser Treatment System is designed to be used dermatology procedures requiring coagulation. The indications for use for the 3 simultaneously wavelength 755,808,1064 nm Laser Module is treatment of benign vascular and vascular dependent lesions.
V Intended use of device and Indications for Use
Intended Use
The Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis, when used with the simultaneous triple wavelength module 755-808-1064 nm, is intended for : · Benign vascular lesions and vascular dependent lesions removal
VI Comparison of technological characteristics with the predicate devices
The indication of the proposed device is covered by the predicated devices. The laser treatment system includes four models of machines and the simultaneous triple wavelength applicator for all four models.
| Device
feature | Laser Treatment System
(subject device) | Modified Alma Lasers
Soprano XL. Family of
Multi-Application &
Multi-Technology
Platforms (K172193) |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Product
code | GEX | GEX |
| Regulation
number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Indications
for use | The indication of use of 3
wavelength 755,808,1064
handpiece (trio is
treatment of Benign
vascular lesions and
vascular dependent
lesions removal | The indication of use of trio
is treatment of Benign
vascular lesions and
vascular dependent lesions
removal |
| Laser
classification | Class IV | Class IV |
5
| Wavelength | The Simultaneous
triple-wavelength laser
device (trio)
755-808-1064 nm | Trio 755-808-1064 nm |
|----------------------|---------------------------------------------------------------------------------|------------------------------------------|
| Frequency | 1-10Hz | 0.53 Hz (HR), 510 Hz(SHR); 2 Hz(LB) |
| Pulse
Duration | 5-300 (to 400 optional) | 3.3-200ms |
| 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
IEC60601-1-2, | Comply with IEC60601-1-2, |
| Laser safety | Comply with IEC60825-1,
IEC60601-2-22 | Comply with IEC60825-1,
IEC60601-2-22 |
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 –intact skin" with a contact duration of "Limited (