(91 days)
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.
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
The provided text does NOT contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding the performance metrics, sample sizes, ground truth establishment, or expert involvement in such studies.
This document is a 510(k) summary for the Quanta Forte device, which focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and compliance with safety, EMC, and software verification standards. It does not present a de novo clinical study with performance metrics against acceptance criteria.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance. The document only mentions:
- Safety and electromagnetic compatibility (EMC) testing: The system complies with IEC 60601-2-22, IEC 60601-2-22, IEC 60601-2-57 for safety and IEC 60601-1-2 for EMC. (These are compliance standards, not performance metrics and acceptance criteria in the context of diagnostic or interpretive AI).
- Software Verification and Validation Testing: Conducted as recommended by FDA guidance. (Again, this is a process, not a performance study).
§ 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.