Manufacturer
Quanta System SpaQuanta Forte
Country / Region:Italy (IT)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K152714
- Device name
- Quanta Forte
- Company
- Quanta System Spa
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2015-09-21
- Decision date
- 2015-12-21
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removalPigment treatmentVascular treatmentAcne treatment
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for 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 415-950nm 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 (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; Anal 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. • 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.
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 415-950nm 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 (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; Anal 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. 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.
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.
Summary parsed at:2026-06-01 06:11:44 UTC
Predicate devices
2—
—
Not ingested
The MeDioStar NeXT Family
K152714 references 2 predicate/reference devices
Cited as predicate
5MT ONE
2940 nm Er:Yag Laser Handpiece
MT One Diamond
Deka Luxea
MT One
5 submissions cite K152714 as a predicate
