# K152714: Quanta Forte

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Dec 21, 2015 after 91 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K943450 (1995). 530 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 544 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143519: The MeDioStar NeXT Family, Asclepion Laser Technologies GmbH (2015) Summary page 5.
- K111303: Dermatological Treatment Device Family, Sharplight Technologies, Ltd. (2011) Summary page 5.

## Most influential descendants
- K172413: MT ONE (2017), 5 descendants of its own
- K192539: Deka Luxea (2019), 4 descendants of its own
- K192856: MT One (2020), 2 descendants of its own
- K203395: Platform treatment system (2022), 1 descendant of its own
- K191942: MT One Diamond (2019), 1 descendant of its own

## 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.

Source page: https://510kreport.com/device/K152714
Methodology: https://510kreport.com/methodology