(54 days)
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.
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.
The provided text describes a 510(k) premarket notification for a laser treatment system (Model: Hera, Armo) intended for hair removal and permanent hair reduction. It focuses heavily on comparing the technological characteristics of the new device to a predicate device (Laser Treatment System, Model: NYX and Grace, K210033) and outlines various performance data, primarily in the areas of biocompatibility, electrical safety, electromagnetic compatibility (EMC), and software verification and validation.
Crucially, the document explicitly states that "The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device." However, it does NOT contain any information about clinical performance studies or studies proving the device meets specific acceptance criteria related to its intended use (hair removal/reduction).
Therefore, I cannot provide the requested information regarding acceptance criteria for device performance based on the specific prompt's requirements, as those details are absent from the provided text. The document refers to "non-clinical testing" and does not detail any studies that would involve human subjects, expert review, ground truth establishment, or statistical analysis typical of device performance efficacy studies.
Thus, I can only state what is not present in the given text:
Based on the provided text, the following information regarding acceptance criteria and performance study details is NOT available:
- A table of acceptance criteria and the reported device performance: The document lists technical specifications but no performance metrics for hair removal/reduction or acceptance criteria for those metrics.
- Sample size used for the test set and the data provenance: No clinical test set or data provenance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set ground truth is discussed.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical laser treatment device.
- The type of ground truth used: Not applicable, as no clinical performance data or ground truth related to hair reduction efficacy is presented.
- The sample size for the training set: Not applicable, as no machine learning model or training set is mentioned.
- How the ground truth for the training set was established: Not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device primarily through technical characteristics and non-clinical safety testing. The "Performance data" section (Section VII) details:
- Biocompatibility testing: Evaluated according to ISO 10993-1, meeting acceptance criteria for Cytotoxicity, Irritation, and Sensitization.
- Electrical safety and electromagnetic compatibility (EMC): Tested to comply with ANSI/AAMI ES60601-1, IEC 60601-1-2.
- Bench Testing: Tested to comply with IEC 60601-2-22 and IEC 60825-1 (laser safety).
- Software Verification and Validation Testing: Conducted and documented as recommended by FDA guidance.
These are all safety and engineering standards compliance rather than performance efficacy data for the device's intended clinical use. The "Conclusion" explicitly states: "The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device." This implies that clinical performance efficacy was not required for this 510(k) clearance, likely due to the substantial equivalence claim based on the predicate device's established performance profile.
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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
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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 systemNyx 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 hairreduction on all skin types(Fitzpatrick skin type I-VI),including tanned skin.Permanent hair reduction isdefined as the long-term,stable reduction in thenumber of hairs regrowingwhen measured at 6, 9, and12 months after thecompletion of a treatmentregime. | System isintended for hairremoval,permanent hairreduction on allskin types(Fitzpatrick skintype I-VI),including tannedskin. Permanenthair reduction isdefined as thelong-term, stablereduction in thenumber of hairsregrowing whenmeasured at 6, 9,and 12 monthsafter thecompletion of atreatmentregime. | |
| Operationprinciple | Melanin could absorb theenergy from the laser, whichwould result in temperaturerapid increase, to destroysurrounding hair follicles, andfinally remove hair. | Melanin couldabsorb theenergy from thelaser, whichwould result intemperaturerapid increase, todestroysurrounding hairfollicles, andfinally removehair. |
| Laserclassification | Class IV | Class IV |
| Light deliverysystem | 808 nm | 808nm |
| Spot Size | 12×12mm12x20mm | 12x12mm |
| 15×27mm | ||
| Fluence | 1 | 1~120 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 (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation and Sensitization. All evaluation acceptance criteria were met
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Laser Treatment System. The system has been tested to comply with the following standards:
- ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and -A2:2010/(R)2012" Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
- IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.
Bench Testing
- IEC 60601-2-22:2007 + A1:2012, 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.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
VIII Conclusion
The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.
§ 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.