(72 days)
Not Found
No
The document describes a laser system for dermatological treatments and does not mention any AI or ML components in the device description, intended use, or performance studies.
Yes.
The device intends to cure, mitigate, or treat diseases and conditions such as benign pigmented lesions, wrinkles, vascular lesions (like port-wine stains, hemangiomas, telangiectasias), tattoos, and onychomycosis, which falls under the definition of a therapeutic device.
No
The device is described as a laser system intended for therapeutic treatments such as hair reduction, treatment of pigmented lesions, wrinkles, and vascular lesions, not for diagnosing medical conditions.
No
The device description explicitly states it is a laser system with two separate laser heads producing light outputs, indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly indicate that this laser system is used to treat conditions on the human body (skin, soft tissue, nails) by applying light directly to the tissue. It does not analyze samples taken from the body.
- The intended uses are therapeutic and cosmetic. The listed indications for use are all related to treating conditions or altering the appearance of the skin, soft tissue, and nails. This is characteristic of a therapeutic or cosmetic device, not an IVD.
- The device description details a laser system for direct application. The description explains how the laser light is delivered to the tissue, which is consistent with a device used for direct treatment.
Therefore, this device falls under the category of a therapeutic or cosmetic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
755mm: Temporary hair reduction. Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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. On all skin types (Fitzpatrick I-VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
1064nm: Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment 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 lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for pigmented lesion size. for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. Temporary increase of clear nail in patients with onychomycosis ( e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
Product codes
GEX
Device Description
Alexandrite Nd:YAG laser Models CPMT CANLASE , CPMT TORLASE contain two separate laser heads (Alexandrite and Nd:YAG), which produce laser light outputs of 755 nm and 1064 nm, respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, Hair follicles, lesions (pigmented, vascular), soft tissue, hypertrophic and keloid scars, nails.
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)
Biocompatibility testing: Biocompatibility of the Laser Treatment System was evaluated in accordance with ISO 10993 for the body contact category of "Surface -intact skin". 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 IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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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November 17, 2022
Canadian Pioneer Medical Technology Corporation (CPMT LASER) Rashid Sayah Managing Director 210 Drumlin Circle. Concord Vaughan, Ontario L4K 3E3 Canada
Re: K222673
Trade/Device Name: Alexandrite and Nd:YAG Laser models CANLASE and TORLASE 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 6, 2022 Received: September 6, 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.
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
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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,
Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, sans-serif font. The text is black against a white background. The letters are clearly legible and evenly spaced.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222673
Device Name
Alexandrite and Nd:YAG laser models CANLASE , TORLASE
Indications for Use (Describe)
755mm:
Temporary hair reduction. Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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. On all skin types (Fitzpatrick I-VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
1064nm:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment 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 lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
The laser is indicated for pigmented lesion size. for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.
Temporary increase of clear nail in patients with onychomycosis ( e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
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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K222673
Section 5 510(k) summary
l Submitter
Canadian Pioneer Medical Technology Corporation (CPMT LASER) 210 Drumlin Circle #2, Vauqhan, 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 06, 2022
II Subject Device
Trade/Device Name: Alexandrite Nd:YAG laser , Models: CANLASE , TORLASE Regulation Number: 21 CFR 878.4810 Requlation 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 Devices
Trade/Device Name: GentleMax Pro Plus 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 510(k) number: K201111
Manufacturer: Candela Corporation
IV Device description
Alexandrite Nd:YAG laser Models CPMT CANLASE , CPMT TORLASE
contain two separate laser heads (Alexandrite and Nd:YAG), which produce laser light outputs of 755 nm and 1064 nm, respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system.
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This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat.
V Indications for use
755nm:
Temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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. On all skin types (Fitzpatrick I- VI) including tanned skin.
Treatment of benign pigmented lesions. Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
1064nm:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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 lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
VI Comparison of technological characteristics with the predicate devices
The indication of proposed device is covered by the predicated devices.
| Device feature | ||
|---|---|---|
| Alexandrite and Nd:YAG Laser | Laser treatment system | |
| (subject device) | GentleMax Family of Laser Systems | |
| (K201111) | ||
| Product code | GEX | GEX |
| Manufacturer | Canadian Pioneer Medical | |
| Technology corporation (CPMT | ||
| LASER) | Candela Corp. | |
| Regulation | ||
| number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Indications for | ||
| use | 755nm: | |
| Temporary hair reduction. Stable | ||
| long-term or permanent reduction | ||
| through selective targeting of | ||
| melanin in hair follicles. Permanent | ||
| hair reduction is defined as | ||
| long-term stable reduction in the | ||
| number of hairs regrowing after a | ||
| treatment regime. 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. On all skin types | ||
| (Fitzpatrick I- VI) including tanned | ||
| skin. | ||
| Treatment of benign pigmented | ||
| lesions. Treatment of wrinkles. | ||
| The photocoagulation of | ||
| dermatological vascular lesions | ||
| (such as port-wine stains, | ||
| hemangiomas, telangiectasias). | ||
| 1064nm: | ||
| Removal of unwanted hair, for | ||
| stable long term or permanent hair | ||
| reduction and for treatment of PFB. | ||
| Permanent hair reduction is | ||
| defined as the long-term, stable | ||
| reduction in the number of hairs | ||
| regrowing when measured at 6, 9 | 755nm: | |
| Temporary hair reduction. | ||
| Stable long-term or permanent | ||
| reduction through selective | ||
| targeting of melanin in hair | ||
| follicles. Permanent hair | ||
| reduction is defined as | ||
| long-term stable reduction in | ||
| the number of hairs regrowing | ||
| after a treatment regime. | ||
| 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. On all skin | ||
| types (Fitzpatrick I- VI) | ||
| including tanned skin. | ||
| Treatment of benign | ||
| pigmented lesions. Treatment | ||
| of wrinkles. | ||
| The photocoagulation of | ||
| dermatological vascular | ||
| lesions (such as port-wine | ||
| stains, hemangiomas, | ||
| telangiectasias). | ||
| 1064nm: | ||
| Removal of unwanted hair, for | ||
| stable long term or permanent | ||
| hair reduction and for | ||
| and 12 months after the | treatment of PFB. Permanent | |
| completion of a treatment regime. | hair reduction is defined as the | |
| The lasers are indicated on all skin | long-term, stable reduction in | |
| types Fitzpatrick I-VI including | the number of hairs regrowing | |
| tanned skin. Photocoagulation and | when measured at 6, 9, and | |
| hemostasis of pigmented and | 12 months after the | |
| vascular lesions such as but not | completion of a treatment | |
| limited to port wine stains, | regime. The lasers are | |
| hemangioma, warts, | indicated on all skin types | |
| telangiectasia, rosacea, venus | Fitzpatrick I-VI including | |
| lake, leg veins and spider veins. | tanned skin. Photocoagulation | |
| Coagulation and hemostasis of soft | and hemostasis of pigmented | |
| tissue. Benign pigmented lesions | and vascular lesions such as | |
| such as, but not limited to, lentigos | but not limited to port wine | |
| (age spots), solar lentigos (sun | stains, hemangioma, warts, | |
| spots), cafe au lait macules, | telangiectasia, rosacea, venus | |
| seborrheic keratosis, nevi, | lake, leg veins and spider | |
| chloasma, verrucae, skin tags, | veins. Coagulation and | |
| keratosis, tattoos (significant | hemostasis of soft tissue. | |
| reduction in the intensity of black | Benign pigmented lesions | |
| and/or blue-black tattoos) and | such as, but not limited to, | |
| plaques. | lentigos (age spots), solar | |
| The laser is indicated for | lentigos (sun spots), cafe au | |
| pigmented lesions to reduce lesion | lait macules, seborrheic | |
| size, for patients with lesions that | keratosis, nevi, chloasma, | |
| would potentially benefit from | verrucae, skin tags, keratosis, | |
| aggressive treatment, and for | tattoos (significant reduction in | |
| patients with lesions that have not | the intensity of black and/or | |
| responded to to other laser | blue-black tattoos) and | |
| treatments. | plaques. | |
| Reduction of red pigmentation in | The laser is indicated for | |
| hypertrophic and keloid scars | pigmented lesions to reduce | |
| where vascularity is an integral | lesion size, for patients with | |
| part of the scar. Treatment of | lesions that would potentially | |
| wrinkles. | benefit from aggressive | |
| Temporary increase of clear nail in | treatment, and for patients | |
| patients with onychomycosis (e.g., | with lesions that have not | |
| dermatophytes, Trichophyton | responded to other laser | |
| rubrum and T. mentagrophytes, | treatments. | |
| and/or yeast Candida Albicans, | Reduction of red pigmentation | |
| etc.) | in hypertrophic and keloid. | |
| scars where vascularity is an | ||
| integral part of the scar. | ||
| Treatment of wrinkles. | ||
| Temporary increase of clear | ||
| nail in patients with | ||
| onychomycosis (e.g., | ||
| dermatophytes, Trichophyton | ||
| rubrum and T. | ||
| mentagrophytes, and/or yeast | ||
| Candida Albicans, etc.) | ||
| Laser Type | Alexandrite and Nd:YAG laser | Alexandrite and Nd:YAG laser |
| Laser | ||
| classification | Class IV | Class IV |
| Wavelength | 755 & 1064 | 755 & 1064 |
| Spot Size | 1.5 mm, 3 mm, 3x10 mm, 5 mm, 6 | |
| mm, 8 mm, 10 mm, 12 mm, 15 | ||
| mm, 18 mm, 20 mm, 22 mm, 24 | ||
| mm, 26 mm | 1.5 mm, 3 mm, 3x10 mm, 5 | |
| mm, 6 mm, 8 mm, 10 mm, 12 | ||
| mm, 15 mm, 18 mm, 20 mm, | ||
| 22 mm, 24 mm, 26 mm | ||
| Frequency | 0.5 - 10Hz | 1-10 Hz |
| Maximum | ||
| Energy (J) | 60 Joules (J) ALEX(optional 70 J) ; 110 | |
| J Nd:YAG | 68 Joules (J) ALEX; 90 J Nd:YAG | |
| Accuracy | ||
| of | ||
| Output | $ \pm $ 20% | $ \pm $ 20% |
| Pulse Duration | 0.25 – 100 ms | 0.25 – 100 ms |
| System | ||
| Cooling | Ambient Air | Ambient Air |
| 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 | Comply with IEC60825-1 |
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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 for the body contact category of "Surface -intact skin" 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:
- । IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements For Basic 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.
VIII Conclusion
The Laser Treatment System is substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.