(54 days)
No
The description mentions a microprocessor for control but does not include any terms or descriptions indicative of AI/ML, such as image processing, deep learning, neural networks, or training/test data sets.
No.
The device is intended for hair removal and permanent hair reduction, which are considered cosmetic procedures rather than therapeutic treatments for a disease or medical condition.
No
The device is intended for hair removal and permanent hair reduction, which are therapeutic and cosmetic procedures, not diagnostic ones. It does not identify or detect conditions but rather treats them.
No
The device description explicitly states it consists of a main unit and a hand piece, uses a diode laser, has a power supply, delivery system, control system, cooling system, and laser system, all of which are hardware components. Software is mentioned only in the context of controlling electronics and undergoing verification and validation testing, not as the sole component 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 on the skin. This is a therapeutic/cosmetic procedure performed directly on the patient's body.
- Device Description: The device is a laser system that delivers energy to the skin. It does not involve the examination of specimens (like blood, urine, tissue) taken from the human body.
- IVD Definition: In Vitro Diagnostics are defined as medical devices and accessories used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
This device clearly falls under the category of a therapeutic or aesthetic medical device, not an IVD.
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 Therapy Devices is designed to be used in dermatological practice for stable, long term hair reduction. The principle of laser hair removal is selective photothermolysis. The wavelength of 808nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system.
The proposed device includes power supply system, delivery system, control system, cooling system, laser system.
The models object of this submission are Armo and Hera:
Hera has one handpiece connector.
Armo has two handpiece connectors.
The 808 nm handpieces with different spot sizes (3 spot sizes : 12×12mm,12×20mm,15×27m) are available for both models.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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
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.
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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
October 25, 2021
Canadian Pioneer Medical Technology Corporation Rashid Reza Mir Sayah Managing Director unit 2, 210 Drumlin Circle, Concord Vaughan, Ontario L4k 3E3 Canada
Re: K212793
Trade/Device Name: Laser Treatment System, Model: Hera, Armo 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: August 26, 2021 Received: September 1, 2021
Dear 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 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) K212793
Device Name
Laser Treatment System, Model: Hera, Armo
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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Section 5 510(k) summary
I 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 Canadianpioneermedical@gmail.com Date of preparation: October 7, 2021
II Subject Device
Trade Name of Device: Laser Treatment System, Model: Hera, Armo 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 Devices: Laser Treatment System, Model: NYX and Grace 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: K210033 Manufacturer: Canadian Pioneer Medical Technology Corporation
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 beam at the
4
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 Therapy Devices is designed to be used in dermatological practice for stable, long term hair reduction. The principle of laser hair removal is selective
photothermolysis. The wavelength of 808nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system.
The proposed device includes power supply system, delivery system, control system, cooling system, laser system.
The models object of this submission are Armo and Hera:
Hera has one handpiece connector.
Armo has two handpiece connectors.
The 808 nm handpieces with different spot sizes (3 spot sizes : 12×12mm,12×20mm,15×27m) are available for both models.
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 indication of proposed device is covered by the predicated devices. The proposed device is only intended to use for hair removal. The device includes three models of handpieces for clearance in this submission. The differences between models are their spot sizes and Density .These are covered by the predicated devices.
| Device feature | Laser Treatment System
(subject device) | Laser treatment system
Nyx and Grace
(K210033) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | GEX | GEX |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Indications for use | The Diode Laser Treatment System is intended for hair | The Diode Laser Treatment |
| | 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. | 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. |
| 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
classification | Class IV | Class IV |
| Light delivery
system | 808 nm | 808nm |
| Spot Size | 12×12mm
12x20mm | 12x12mm |
| | 15×27mm | |
| Fluence | 1120J/cm² at spot size 12×12mm70 J/cm² at spot size12×20mm
1
140 J/cm² at spot size15×27mm | 1120 J/cm² |
| Frequency | 1-10Hz | 1-10 Hz |
| Pulse Duration | 10-300ms | 10-300 ms |
| 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 IEC60601-1-2, | Comply with IEC60601-1-2, |
| Laser safety | Comply with IEC60825-1, IEC60601-2-22 | Comply with IEC60825-1, IEC60601-2-22 |
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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 (