# K223404: Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V

- Pathway: 510(k) (Special)
- Applicant: Quanta System Spa
- Decided: Jan 20, 2023 after 72 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: 27 generations back to K943450 (1995). 300 ancestors in all.
No later device cites it as a predicate yet.
0 of 301 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192160: EVO Platform, Quanta System Spa (2019) Summary page 5.
- K202503: Chrome, Quanta System Spa (2020) Summary page 5.

## Indications for use
Suprema Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows. 1064 nm (pulsed) Dermatology/Plastic Surgery: Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The laser is also indicated for the treatment of facial wrinkles. Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as 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. It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The laser is also 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. It is indicated for use on all skin types (Fitzpatrick 1-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick 1-VI, including suntanned skin types. 532 nm (pulsed) Intended for the coagulation and hemostasis of vascular lesions. Dermatology/Plastic Surgery: For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including but not limited to the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or ex-tremities telangiectasias, venous anomalies, leg veins]; benign pigmented lesions (nevi, lentigines, chloasma, cafe au- lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size). 755 nm (pulsed) Indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re-growing when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick 1-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. IPL 590-1200nm; 625-1200nm; 650-1200nm Indicated for permanent hair removal. 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. IPL 550-1200nm; 570-1200nm Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions. IPL 400-1200nm Indicated for inflammatory acne (acne vulgaris). Integrated Skin Cooler The intended use of the integrated cooling system in Suprema Family is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.

Source page: https://510kreport.com/device/K223404
Methodology: https://510kreport.com/methodology