Manufacturer
Quanta System SpaDuetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
Country / Region:Italy (IT)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
- Company
- Quanta System Spa
- 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—
—
Not ingested
2940 nm Er:Yag Laser Handpiece
EVO Platform
Chrome
K223404 references 4 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K223404 as a predicate
