Thunder, Thunder VT, Thunder HR

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

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K171711
Device name
Thunder, Thunder VT, Thunder HR
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2017-06-09
Decision date
2017-07-07
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

The THUNDER 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.

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 I-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

Indicated 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 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

The intended use of the integrated cooling system in the Thunder 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.

Intended Use

The THUNDER 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. Indicated for the coagulation and hemostasis of benign vascular lesions such as port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis; treatment of benign pigmented lesions such as lentigos, solar lentigos, cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques; treatment of wrinkles; treatment of pseudofolliculitis barbae (PFB); stable long-term, or permanent hair reduction; reduction of red pigmentation in hypertrophic and keloid scars; indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin.

Device Description

The Thunder family includes devices that utilize 1064 nm and 755 nm pulsed lasers. The integrated cooling system provides cooling of the skin prior to laser treatment, reduces pain during treatment, allows for higher fluences, and minimizes potential side effects.

Summary parsed at:2026-06-01 06:00:23 UTC

Predicate devices

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