Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V

Quanta System Spa

Country / region:Italy (IT)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

4

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K223404
Device name
Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-11-09
Decision date
2023-01-20
Submission type
Special
Technology type
Nd:YAG(AI inferred)
Clinical applications
Vascular treatmentSurgical cutting
Primary application
Vascular treatment
Classification source
AI classified

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.

Indications for use:

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, telangiectasia, 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.
- 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 extremities 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 les

Intended 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. Indications for use include coagulation and hemostasis of benign vascular lesions, treatment of benign cutaneous lesions, treatment of wrinkles, stable long-term hair reduction, and reduction of red pigmentation in hypertrophic and keloid scars.

Device Description

Suprema family includes medical laser devices for dermatology and aesthetic medicine. It is used by health care professionals (dermatologists) in professional healthcare environments for the treatment of different skin conditions and hair removal. Suprema devices are transportable mobile electrical equipment with a display with a graphical user interface (GUI) for user-device interaction. Laser radiation is delivered through optical fibers connected to handpieces having fix or variable spot dimension. The device can be optionally equipped with an integrated skin cooler. Suprema devices can be used in conjunction with Twain IPL and Twain 2940 devices.

Summary parsed at:2026-06-01 05:32:11 UTC

Predicate devices

4

K223404 references 4 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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