Superbium

Bios S.R.L.

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

Product code GEX· 21 CFR 878.4810

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Company

Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

7

Cited as predicate

2

Device details

FDA 510(k) registration fields

K number
K153229
Device name
Superbium
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2015-11-06
Decision date
2016-04-12
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Vascular treatmentPigment treatmentAcne treatment
Primary application
Vascular treatment
Classification source
AI classified

Indications for Use

The Nd:Yag 1064 Laser Handpiece (Long Pulsed) is intended for:
-treatment of benign vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins;
-treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques;
-tattoos (significant reduction in the intensity of black and/or blue-black tattoos);
verrucae, skin tags, seborrheic keratosis;
- reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar;
- coagulation and hemostasis of soft tissue;
-the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction. Permanent reduction in hair regrowth 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.

The Nd:Yag 1064 Laser Handpiece (Short Pulsed) is intended for:
Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions
Laser skin treatment procedures for the treatment of: Acne scars, Wrinkles

The Nd:YAG Q-Switched Handpieces (1064 nm) are indicated for treatment of:
- Benign vascular lesions such as, but not limited to treatment of:
Port wine stains; Hemangiomas; Warts; Superficial and deep telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas
-Benign cutaneous lesions, such as, but not limited to:
Warts; Scars; Striae; Psoriasis
-Benign pigmented lesions such as, but not limited to:
Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Seborrheic keratoses; Nevi and nevus of Ota; Chloasma; Verrucae; Skin tags; Keratoses; The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos); Plaques
- Pigmented benign 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.
- The non-ablative treatment of facial wrinkles, such as, but not limited to:
Periocular wrinkles; Perioral wrinkles;
-Laser skin resurfacing procedures for the treatment of:
Acne scars; Wrinkles
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
-Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Nd:YAG Q-Switched Handpieces (532 nm) are indicated for treatment of:
-Incision, excision, ablation, vaporization of soft tissue.
- Tattoo removal: Light blue; Yellow; Red; Green
-Vascular lesions: Hemangiomas (Port wine stains/birthmarks,  cavernous, cherry, spider, hemangiomas); Angiomas (cherry, spider); Telangiectasia; Spider nevi

Intended Use

The Nd:Yag 1064 Laser Handpiece (Long Pulsed) is intended for: - treatment of benign vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins; - treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques; - tattoos (significant reduction in the intensity of black and/or blue-black tattoos); verrucae, skin tags, seborrheic keratosis; - reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; - coagulation and hemostasis of soft tissue; - the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction. Permanent reduction in hair regrowth 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

The portable device SUPERBIUM, is a multilaser and pulsed light system, designated to act on some common conditions of face and body. The equipment is designed as an expandable system for dermatologic and general surgery procedures, composed of a modular platform, which contains the entire electronics of the system and the cooling circuit, and a series of interchangeable handpieces to be connected on the platform, intended to treat specific groups of imperfections. A quick connection enables the quick and easy replacement of the various hand pieces that can be mounted on the modular platform. The following handpieces are available: 1) Handpiece Nd:Yag Laser contains a flash lamp excited source that emits at 1064nm, with 2 different modalities: long pulse (ms) and short pulse (µs). The handpiece can be equipped with different spots and also with an optical fiber. A pointing laser helps to guide the operator during the treatment. With this laser it is possible to treat vascular lesions, pigmented lesions, tattoos, scars, soft tissue, hair removal treatments (long pulse) and pigmented and vascular lesions, wrinkles and podiatry (short pulse). This laser is class IV according to the Standard EN60825-1. 2) Handpiece Nd:Yag Laser contains a flash lamp excited source that emits 1064 and 532 nm Qs (Q-Switched). The pulse duration is very short (ns), typical characteristic of QS lasers. The handpiece can be equipped with different spots. A pointing laser helps to guide the operator during the treatment. The Qs laser is ideal for the treatment of vascular lesions, scars, pigmented lesions, skin resurfacing (1064 nm) and soft tissue, tattoo, vascular lesions, pigmented lesions (532 nm). This laser is class IV according to the Standard EN60825-1. 3) Handpiece Erbium Laser contains a flash lamp excited source that emits at 2940 nm. The handpiece can be equipped with different spots; two of them are fractional, so they divide the shot in several microbeams. The Er:Yag laser is ideal for soft tissue, skin resurfacing, skin lesions treatments. This laser is class IV according to the Standard EN60825-1. 4) Handpiece Erbium Glass Laser contains a flash lamp excited source that emits at 1540 nm. The handpiece can be equipped with two spots, both fractional, that divide the shot in several microbeams. The Er:Glass is ideal for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue, for example scar treatments. This laser is class IV accordi

Summary parsed at:2026-06-01 06:05:27 UTC

Predicate devices

7

K153229 references 7 predicate/reference devices

Cited as predicate

2

2 submissions cite K153229 as a predicate