(273 days)
Not Found
No
The description focuses on the physical components and energy delivery mechanism of a CO2 laser system, with no mention of AI or ML capabilities. The performance studies listed are standard electrical, laser safety, biocompatibility, and software verification tests, not AI/ML performance evaluations.
Yes
The device is used for incision, excision, ablation, vaporization, and coagulation of body soft tissues, which are therapeutic actions.
No
The device description and intended use clearly state that the CO2 Laser System is for surgical procedures (incision, excision, ablation, vaporization, coagulation) and not for diagnosing medical conditions.
No
The device description explicitly states it is a "CO2 Laser System" comprised of "multiple components, including the control unit and handpieces," and that "Laser is transmitted to the tissue via a series of lenses integrated into the articulated arm." This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes surgical procedures on body soft tissues (incision, excision, ablation, vaporization, coagulation, and skin resurfacing). This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The device is a CO2 laser system that delivers energy to tissue. This is a physical intervention, not a diagnostic test performed on samples taken from the body.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This CO2 laser system is a therapeutic device used for surgical procedures.
N/A
Intended Use / Indications for Use
CO2 Laser System is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiaty, otolaryngology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Product codes
GEX
Device Description
The CO2 Laser System is a computer controlled radiofrequency (RF) excited carbon dioxide (CO2) laser system that delivers CO2 energy to the target treatment area at 10,600 nm. The CO2 Laser System is comprised of multiple components, including the control unit and handpieces. Laser is transmitted to the tissue via a series of lenses integrated into the articulated arm. The CO2 laser energy is absorbed by water in tissue to achieve its intended treatment effects.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body soft tissues, skin
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 tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The following tests were conducted:
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements For Basic i Safety and Essential Performance.
- IEC 60601-2-22. 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, Safety of laser products Part 1: Equipment classification and requirements.
- IEC 60601-1-2 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
- Biocompatibility Performance per ISO 10993 and FDA Guidance -
- Software Verification and Validation -
- Bench Testing -
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
April 16, 2024
CPMT Laser (Canadian Pioneer Medical Technology Corporation) Rashid Sayah Managing Director 460 Garyray Drive, North York Toronto. Ontario M9L 1P8 Canada
Re: K232133
Trade/Device Name: CO2 Laser System (Models: PureLase And VanLase) 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 13, 2024 Received: March 13, 2024
Dear Rashid 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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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,
Tanisha L. Digitally signed by Hithe -S Date: 2024.04.16 14:35:43 -04'00'
Tanisha Hithe 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) K232133
Device Name
CO2 Laser System (Models: Purelase and Vanlase)
Indications for Use (Describe)
CO2 Laser System is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiaty, otolaryngology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
| 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 K232133
This 510(k) Summary is being submitted in accordance with requirements of 21CFR Section 807.92.
l Submitter
CPMT LASER (Canadian Pioneer Medical Technology Corporation) 460 Garyray Drive, North York, Toronto, ON, M9L 1P8, Canada
Contact person: Dr. Rashid Reza Mir Sayah Managing Director Phone: 4377727788 Email: Canadianpioneer@yahoo.com Canadianpioneermedical@gmail.com Date of preparation: April 15, 2024
II Subject Device
Trade/Device Name: CO2 Laser System (Models: Purelase and Vanlase) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: II Product code: GEX Manufacturer: Canadian Pioneer Medical Technology Corporation
III Predicate Device
Trade/Device Name: EdgeOne CO2 Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: II Product code: GEX 510(k) number: K162169 Manufacturer: Jeisys Medical Inc.
IV Device description
The CO2 Laser System is a computer controlled radiofrequency (RF) excited carbon dioxide (CO2) laser system that delivers CO2 energy to the target treatment area at 10,600 nm. The CO2 Laser System is comprised of multiple components, including the control unit and handpieces. Laser is transmitted to the tissue via a series of lenses integrated into the
5
articulated arm. The CO2 laser energy is absorbed by water in tissue to achieve its intended treatment effects.
V Indications for use
CO2 Laser System is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology(ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
VI Substantial Equivalence Comparison
Comparison of the Indications for Use: The indications for use of the subject device is comparable to the indications for use of the predicate device.
| Device & Predicate Device(s): | K232133 | K162169 |
|---|---|---|
| General Device Characteristics | ||
| Laser | CO2 | CO2 |
| Wavelenghts (nm) | 10600 | 10600 |
| Power Output (W) | 1-30 W | ≤ 30W |
| Pulse Duration | 1-1000 ms | 1-1000 ms |
| Repetition Rate (Hz) | 1-500 | 10-500 |
| Scan Area (mm²) | 1x1 - 20x20 | 15 X 15 |
| Surgical Handpieces (µm) | µablative tip: 350-500 | |
| non-ablative tip: 800-1200 | 150, 1000 | |
| Beam Divergence | 7.5±0.5 mrad | Unavailable |
Comparison of technology:
VII Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The following tests were conducted:
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements For Basic i Safety and Essential Performance.
- IEC 60601-2-22. 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, Safety of laser products Part 1: Equipment classification and requirements.
- IEC 60601-1-2 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
- Biocompatibility Performance per ISO 10993 and FDA Guidance -
- Software Verification and Validation -
- Bench Testing -
VIII Conclusion
Based on the comparison and analysis above, the proposed subject device is determined to be Substantially Equivalent (SE) to the predicate device.