(91 days)
Not Found
No
The document describes a laser and IPL device with a microprocessor-based system controller. There is no mention of AI, ML, or any features that would typically utilize these technologies, such as image analysis for treatment planning or automated parameter adjustments based on patient data. The performance studies focus on safety, EMC, and software verification/validation, not AI/ML performance metrics.
Yes
The device is indicated for the treatment of various medical conditions such as benign vascular lesions, benign pigmented lesions, inflammatory acne, pigmented and vascular lesions, wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, keratoses, and scar revision. These are all therapeutic applications.
No
The device description and intended uses clearly state that Quanta Forte is an IPL and laser emitting device used for aesthetic and medical treatments (e.g., hair removal, lesion treatment, skin resurfacing). It is a therapy device, not a diagnostic one.
No
The device description clearly states it is an Intense Pulsed Light (IPL) and laser emitting device with a main console unit and several handpieces, indicating it is a hardware device with integrated software.
Based on the provided information, the Quanta Forte device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "aesthetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery." The specific indications listed are for treating various skin conditions, hair removal, and skin resurfacing. These are all procedures performed directly on the patient's body.
- Device Description: The device description confirms it's an "Intense Pulsed Light (IPL) and laser emitting device that is operated with a handpiece in contact with the skin." This describes a device used for external treatment.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or analysis of biological materials.
The Quanta Forte is a therapeutic device that uses light and laser energy to treat conditions directly on the patient's skin.
N/A
Intended Use / Indications for Use
Quanta Forte and its Hand Pieces are intended for use in aesthetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery.
Quanta Forte with 808nm Laser Handpiece is indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*.
Quanta Forte with 415-950nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale.
Quanta Forte with 535-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Pigmented and Vascular Lesions in all skin types (1-VI) to the Fitzpatrick Scale.
Quanta Forte with 580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick scale.
Quanta Forte with 580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale.
Quanta Forte with 635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for Hair removal and Permanent Hair Reduction* in all skin types (1-VI) to the Fitzpatrick scale.
Quanta Forte with 2940 nm Er-Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to:
Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).
Quanta Forte with 1064 nm Long Pulse (LP) Nd: Y AG Laser Handpiece is indicated for:
· Removal of unwanted hair, for stable long-term, or permanent, hair reduction* through selective targeting of melanin in hair follicles.
· Removal or lightening of unwanted hair (with and without adjuvant preparation)
· Treatment of pseudofolliculitis barbae (PEB)
- 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, ONF
Device Description
Quanta Forte system is an Intense Pulsed Light (IPL) and laser emitting device that is operated with a handpiece in contact with the skin.
Quanta Forte comprises a main console unit and several handpieces that are triggered by means of a footswitch or a finger switch.
A microprocessor based system controller is used to monitor and direct all the system functions and the graphic user interface.
The main console can be connected to the following handpieces:
- -415-950 nm Intense Pulsed Light
- 535-950 nm Intense Pulsed Light .
- -580-950 nm Intense Pulsed Light
- -635-950 nm Intense Pulsed Light
- -808 nm laser diode
- -1064 nm ND:YAG laser
- -2940 nm Erbium:YAG laser
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, cutaneous tissue, hair follicles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical specialties of dermatology and general and plastic surgery.
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 are provided in support of the substantial equivalence determination:
Safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Quanta Forte device. The system complies with the IEC 60601-2-22, IEC 60601-2-22, IEC 60601-2-57 standards for safety and the IEC 60601-1-2 standard for EMC.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and uses a single color, which appears to be black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2015
Quanta System SPA Francesco Dell'antonio Head of Regulatory Affairs Department Via IV Novembre, 116 Solbiate Olona (VA), 21058 IT
Re: K152714 Trade/Device Name: Quanta Forte 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, ONF Dated: November 23, 2015 Received: December 3, 2015
Dear Mr. Dell'antonio:
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. 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Binita S. Ashar -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152714
Device Name Quanta Forte
Indications for Use (Describe)
Ouanta Forte and its Hand Pieces are intended for use in aesthetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery.
Quanta Forte with 808nm Laser Handpiece is indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*.
Quanta Forte with 415-950nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale.
Quanta Forte with 535-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Pigmented and Vascular Lesions in all skin types (1-VI) to the Fitzpatrick Scale.
Quanta Forte with 580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick scale.
Quanta Forte with 580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale.
Quanta Forte with 635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for Hair removal and Permanent Hair Reduction* in all skin types (1-VI) to the Fitzpatrick scale.
Quanta Forte with 2940 nm Er-Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to:
Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).
Quanta Forte with 1064 nm Long Pulse (LP) Nd: Y AG Laser Handpiece is indicated for:
· Removal of unwanted hair, for stable long-term, or permanent, hair reduction* through selective targeting of melanin in hair follicles.
· Removal or lightening of unwanted hair (with and without adjuvant preparation)
· Treatment of pseudofolliculitis barbae (PEB)
- 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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5. 510(K) SUMMARY
Introduction:
This document contains the 510(k) Summary for the Quanta Forte device. The content of this summary is based on the requirements of 21 CFR 807.92(c).
| Applicant / Manufacturer Name and Address: | Quanta System SPA Via IV Novembre, 116 Solbiate Olona (VA) Italy, 21058 |
|---|---|
| 510(k) Contact Person: | Francesco Dell'Antonio Head of Regulatory Affairs dept Quanta System SPA Email: francesco.dellantonio@quantasystem.com Phone: +39-0331-376797 Fax: +39-0331-367815 |
| Date Prepared: | 14/09/2015 |
| Device Name: | Quanta Forte |
| Classification: | Class II |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology. |
| Regulation Number: | 21 CFR 878.4810 |
Predicate Devices:
Quanta Forte is substantially equivalent to the following legally marketed predicate devices:
- K143519 Mediostar Next Family - Asclepion Laser Technologies Gmbh
- . K111303 Omnimax - Sharplight Technologies Ltd
Description of the device:
Quanta Forte system is an Intense Pulsed Light (IPL) and laser emitting device that is operated with a handpiece in contact with the skin.
Quanta Forte comprises a main console unit and several handpieces that are triggered by means of a footswitch or a finger switch.
A microprocessor based system controller is used to monitor and direct all the system functions and the graphic user interface.
5
The main console can be connected to the following handpieces:
- -415-950 nm Intense Pulsed Light
- 535-950 nm Intense Pulsed Light .
- -580-950 nm Intense Pulsed Light
- -635-950 nm Intense Pulsed Light
- -808 nm laser diode
- -1064 nm ND:YAG laser
- -2940 nm Erbium:YAG laser
Intended use
Quanta Forte and its Hand Pieces are intended for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery.
Quanta Forte with 808nm Laser Handpiece is indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*.
Quanta Forte with 415-95onm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Inflammatory Acne vulgaris) in skin types (I-V) to the Fitzpatrick scale.
Quanta Forte with 535-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick Scale.
Quanta Forte with 580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick scale.
Quanta Forte with 580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale.
Quanta Forte with 635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for Hair removal and Permanent Hair Reduction* in all skin types (I-VI) to the Fitzpatrick scale.
Quanta Forte with 2940 nm Er-Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to:
Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).
Quanta Forte with 1064 nm Long Pulse (LP) Nd:YAG Laser Handpiece is indicated for: Removal of unwanted hair, for stable long-term, or permanent, hair reduction* through selective targeting of melanin in hair follicles.
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Removal or lightening of unwanted hair (with and without adjuvant preparation) Treatment of pseudofolliculitis barbae (PEB)
- 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.
Comparison of Technological Characteristics:
Quanta Forte has the same technological characteristics (energy source, laser/IPL source, control mechanism) and specifications as its predicate devices.
Performance data:
The following performance data are provided in support of the substantial equivalence determination:
Safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Quanta Forte device. The system complies with the IEC 60601-2-22, IEC 60601-2-22, IEC 60601-2-57 standards for safety and the IEC 60601-1-2 standard for EMC.
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".
Comparison of Intended Use:
Quanta Forte device's Intended Use combines the Intended Uses of its predicate devices.
Substantial Equivalence:
The Quanta Forte device is as safe and effective as its predicate devices. The Quanta Forte device has the same intended use and same technological characteristics and specifications as its predicate devices.
Thus, Quanta Forte device is substantially equivalent to its predicate devices.