(50 days)
Not Found
No
The document describes a laser system with different wavelengths and handpieces for dermatological procedures. It mentions a microprocessor for control but does not include any language or descriptions indicative of AI or ML capabilities, such as image processing, data analysis for diagnosis or treatment planning, or adaptive algorithms.
Yes
The device is intended for various medical procedures, including hair removal, treatment of pseudofolliculitis barbae, and removal of benign vascular and pigmented lesions, which directly address a medical condition or alter the structure or function of the body, classifying it as therapeutic.
No
This device is a therapeutic laser system used for procedures like hair removal and the treatment of benign vascular/pigmented lesions, not for diagnosing conditions.
No
The device description explicitly details hardware components such as a main unit, hand piece, diode laser, optical cavity, power supply unit, and a water cooling system. While it mentions a microprocessor for control, the core functionality and delivery of treatment are based on physical laser technology and associated hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for dermatologic and general surgical procedures, specifically for hair removal and the treatment of benign vascular and pigmented lesions. These are procedures 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 derived from the human body (like blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This laser system is a therapeutic device used for treatment.
N/A
Intended Use / Indications for Use
The Quadruple Laser System has 4 types of handles : 755 nm , 808nm and 1064 nm and simultaneous triple wavelength 755/808/1064nm.
Intended Use
The device is intended for use in dermatologic and general surgical procedures.
The simultaneous triple wavelength handpiece is intended for use in dermatology procedures requiring coagulation. The indications for use for the Triple wavelength handpiece include: Benign vascular and vascular dependent lesions removal.
The indications for use for the handpiece of 1064nm include:
- The Hair Removal is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
- Treatment of Pseudo folliculitis Barbae (PFB)
- Use on all skin types (Fitzpatrick I-VI), including tanned skin.
The indications for use for the handpiece of 808 nm include:
- The Hair Removal (HR) is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
- The treatment of benign vascular and pigmented lesions.
- Use on all skin types (Fitzpatrick I-VI), including tanned skin.
The indications for use for the handpiece of 755 nm include:
- The Hair Removal (HR) is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
- The treatment of benign vascular and pigmented lesions.
- Use on all skin types (Fitzpatrick I-VI), including tanned skin.
Product codes
GEX
Device Description
The Quadruple Laser 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. 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 device 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, 755, and 1064nm 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, control system, control system, cooling system, laser system.
The 755nm, 808 nm, 1064nm handpieces with different treatment sizes are available for different 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
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.
November 15, 2022
Canadian Pioneer Medical Technology Corporation (CPMT LASER) Rashid Sayah Managing Director 210 Drumlin Circle #2, Concord Vaugham. Ontario L4K 3E3 Canada
Re: K222915
Trade/Device Name: Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS 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: September 26, 2022 Received: September 26, 2022
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 (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 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.
Jianting Wang -S
Jianting Wang Acting 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
2
Indications for Use
510(k) Number (if known)
K222915
Device Name
Quadruple Laser System , Models : CPMT ARES . CPMT NEMESIS , CPMT GRACE PLUS , CPMT NYX PLUS
Indications for Use (Describe)
The Quadruple Laser System has 4 types of handles : 755 nm , 808nm and 1064 nm and simultaneous triple wavelength 755/808/1064nm .
Intended Use
The device is intended for use in dermatologic and general surgical procedures.
The simultaneous triple wavelength handpiece is intended for use in dermatology procedures requiring coagulation. The indications for use for the Triple wavelength handpiece include: Benign vascular and vascular dependent lesions removal.
The indications for use for the handpiece of 1064nm include:
- -The Hair Removal is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
- Treatment of Pseudo folliculitis Barbae (PFB) -
- Use on all skin types (Fitzpatrick I-VI), including tanned skin. -
The indications for use for the handpiece of 808 nm include:
- -The Hair Removal (HR) is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
- The treatment of benign vascular and pigmented lesions. -
- -Use on all skin types (Fitzpatrick I-VI), including tanned skin.
The indications for use for the handpiece of 755 nm include:
- The Hair Removal (HR) is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
- The treatment of benign vascular and pigmented lesions. -
- -Use on all skin types (Fitzpatrick I-VI), including tanned skin.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
3
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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510(k) summary
K222915
I Submitter
Canadian Pioneer Medical Technology Corporation (CPMT LASER) 210 Drumlin Circle#2 , 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: Sep 17, 2022
II Subject Device
Trade Name of Device: The Quadruple Laser System, Model: CPMT Nyx Plus , CPMT Grace Plus, CPMT ARES, CPMT 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 Devices
Trade Name of Device: 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 510(k) number: K211722 2. 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
5
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 Quadruple Laser 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. 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 device 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, 755, and 1064nm 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, control system, control system, cooling system, laser system.
The 755nm, 808 nm, 1064nm handpieces with different treatment sizes are available for different models.
V Indications for use
The Quadruple Laser System has 4 types of handles : 755 nm , 808nm and 1064 nm and simultaneous triple wavelength
755/808/1064nm .
Intended Use
The device is intended for use in dermatologic and general surgical procedures..
The simultaneous triple wavelength handpiece is intended for use in dermatology procedures requiring coagulation. The indications for the Triple wavelength handpiece include:
Benign vascular and vascular dependent lesions removal.
The indications for use for the handpiece of 1064nm include:
-
The Hair Removal is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
-
Treatment of Pseudo folliculitis Barbae (PFB)
-
Use on all skin types (Fitzpatrick I-VI), including tanned skin.
6
The indications for use for the handpiece of 808 nm include:
-
The Hair Removal (HR) is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
-
The treatment of benign vascular and pigmented lesions.
-
Use on all skin types (Fitzpatrick I-VI), including tanned skin.
The indications for use for the handpiece of 755 nm include:
-
The Hair Removal (HR) is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
-
The treatment of benign vascular and pigmented lesions.
-
Use on all skin types (Fitzpatrick I-VI), including tanned skin.
VI Comparison of technological characteristics with the predicate devices
The indication of proposed device is covered by the predicated devices. The proposed device is intended to use for hair removal on all skin types and Benign Vascular lesions and vascular dependent lesions removal.
The device includes four models for clearance in this submission. The differences between models are on their appearance and number of the connectors.These models are covered by the predicated devices.
| Device feature | Quadruple Laser
System
models CPMT Nyx plus,
CPMT Grace plus,
CPMT Nemesis, CPMT
Ares (K222915) | Laser treatment system ,
models Nyx plus, Grace
plus, Nemesis, Ares
(K211722) | Alma Lasers Soprano
family
(K172193) |
|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | GEX | GEX | GEX |
| Regulation
number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Manufacturer | CPMT LASER
(Canadian Pioneer Medical
Technology Corporation) | CPMT LASER
(Canadian Pioneer Medical
Technology Corporation) | Alma Lasers Inc. |
| Indications for use:
The Simultaneous
Triple Wavelength
Handpiece
(755/808/1064)nm | intended for use in
dermatology procedures
requiring coagulation.
The indications for use for
the Triple wavelength
handpiece include:
• Benign vascular and
vascular dependent | intended for use in
dermatology procedures
requiring coagulation.
The indications for use for
the Triple wavelength
handpiece include:
• Benign vascular and
vascular dependent | intended for use in
dermatology procedures
requiring coagulation.
The indications for use for
the Triple wavelength
handpiece include:
• Benign vascular and
vascular dependent |
| | lesions removal. | lesions removal. | lesions removal. |
| | | | |
| The indications for
use for the
Handpiece of
1064nm | • The Hair Removal is
intended for permanent
reduction in hair
regrowth defined as a
long term, stable
reduction in the number
of hairs re-growing
when measured at 6, 9
and 12 months after
the completion of a
treatment regimen.
• Treatment of Pseudo
folliculitis Barbae
(PFB)
• Use on all skin types
(Fitzpatrick I-VI),
including tanned skin. | N/A | • Permanent reduction in
hair regrowth in HR and
SHR Mode
• Treatment of Pseudo
folliculitis Barbae
(PFB)
• Use on all skin types
(Fitzpatrick I-VI),
including tanned skin |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| The indications for
use for the
handpiece of 808
nm | • The Hair Removal (HR)
is intended for permanent
reduction in hair
regrowth defined as a
long term, stable
reduction in the number
of hairs re-growing when
measured at 6, 9 and 12
months after the
completion of a treatment
regimen.
• The treatment of benign
vascular and pigmented
lesions.
• Use on all skin types
(Fitzpatrick I-VI) | N/A | (810nm):
• The Hair Removal (HR)
and Super Hair Removal
(SHR) Mode are
intended for permanent
reduction in hair
regrowth defined as a
long term, stable
reduction in the number
of hairs re-growing when
measured at 6,9 and 12
months after the
completion of a treatment
regimen.
• The treatment of benign
vascular and pigmented |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | including tanned skin. | | lesions.(The Laser
Blanch (LB) Mode)
• Use on all skin types
(Fitzpatrick I-VI),
including tanned skin.
(HR, SHR and LB
Modes) |
| The indications for
use for the
Handpiece of 755 nm | The Hair Removal (HR) is
intended for permanent
reduction in hair regrowth
defined as a long term, stable
reduction in the number of
hairs re-growing when
measured at 6,9 and 12
months after the completion
of a treatment regimen.
- The treatment of benign
vascular and pigmented
lesions. - Use on all skin types
(Fitzpatrick I-VI), including
tanned skin. | N/A | • The Hair Removal (HR)
and Super Hair Removal
(SHR) Mode are
intended for permanent
reduction in hair
regrowth defined as a
long term, stable
reduction in the number
of hairs re-growing when
measured at 6,9 and 12
months after the
completion of a treatment
regimen.
• The treatment of benign
vascular and pigmented
lesions.(The Laser
Blanch Mode)
• Use on all skin types
(Fitzpatrick I-VI),
including tanned
skin.(HR, SHR and Laser
Blanch Modes) |
| Laser classification | Class IV | Class IV | Class IV |
| 755nm handpiece | Laser medium: Semi-
conductor | N/A | Laser medium: solid state |
| | Spot size: 1212 mm
(optional 1527 mm) | | Spot size: 1510mm
(1.5cm2) |
| | | | Pulse duration: 3.3-200ms |
| | | | |
| | Pulse duration: 1-400 ms
Energy density (fluence):
Up to 120 J/cm² at 1212 mm
(Fluence up to 42 J/cm² at optional 1527 mm )
Repetition rate: 0.5-10 Hz | | Energy density (fluence)
[HR]:
2-120 J/cm²
Repetition rate [HR]: 0.5-3 Hz |
| 808nm nm handpiece | Laser medium: Semi conductor
Spot size: 1212 mm
(optional 1527 mm)
Pulse duration: 1-400 ms
Energy density (fluence):
Up to 120 J/cm² at 1212 mm
(Fluence up to 42 J/cm² at optional 1527 mm )
Repetition rate: 0.5-10 Hz | N/A | (810nm):
Laser medium: solid state
Spot size: 1210mm (1.2cm²)
2010 mm (2cm²)
Pulse duration: 3.3-200ms
Energy density (fluence)
[HR]:
2-120 J/cm²
Frequency [HR]: 0.5-3 Hz |
| 1064nm wavelength | Laser medium: Semi conductor
Spot size: 1212 mm
(optional 1527 mm)
Pulse duration: 1-400 ms
Energy density (fluence):
Up to 120 J/cm² at 1212 mm
(Fluence up to 42 J/cm² at optional 1527 mm ) | N/A | Laser medium: Solid state
Spot size: 10mm10mm (1cm2) ; Optional tapered tip 6mm (0.28 cm2)
Pulse duration: 3.3-280ms
Energy density (fluence)
[HR]:
2-120 J/cm²
Frequency: 0.5-3 Hz (HR),
5-10 Hz(SHR): 2 Hz(LB) |
| | Repetition rate: 0.5-10 Hz | | |
| Simultaneous
triple-wavelength
handpiece
(755/808/1064nm) | Spot size: 1212 mm
(optional 1527 mm)
Pulse duration: 1-400ms
Energy density (fluence):
Up to 120 J/cm2 at 1212 mm
(Fluence up to 42 J/cm2 at optional 1527 mm )
Repetition rate: 0.5-10 Hz | Spot size: 1212 mm
(optional 1527 mm)
Pulse duration: 5-300ms
(400 optional)
Energy density (fluence):
Up to 120 J/cm2
Repetition rate: 1-10 H | 755/810/1064 nm (Trio):
Spot size: n/a
Pulse duration: n/a
Energy density (fluence):
n/a
Repetition rate: n/a |
| Power supply | 100-240V AC,
50/60Hz | 100-240V AC,
50/60Hz | 100-240V AC,
50/60Hz |
| Biocompatibility | Comply with
ISO10993-1 | Comply with
ISO10993-1 | Comply with
ISO10993-1 |
| Electrical Safety | Comply with
IEC60601-1,
IEC60601-2-22 | 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 | Comply with IEC60601-1-2 |
| Laser safety | Comply with
IEC60825-1,
IEC60601-2-22 | 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
11
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 (