Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)

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

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Device details

FDA 510(k) registration fields

K number
K243445
Device name
Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-11-06
Decision date
2024-12-30
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Hair removalVascular treatmentPigment treatment
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The Nd:YAG 1064 Laser is intended for:
• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of Pseudofolliculitis Barbae (PFB). 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. The lasers are indicated on all skin types, such as Fitzpatrick I-VI, including tanned skin.
• Photocoagulation and hemostasis of benign pigmented and vascular lesions such as but not limited to port-wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
• Coagulation and hemostasis of soft tissue.
• Treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sunspots cafè au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis), tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with benign lesions that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments.
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Treatment of wrinkles.
• Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.).
The Alexandrite 755 laser is intended for:
• Temporary hair reduction.
• Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. 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. On all skin types, such as Fitzpatrick I – VI, including tanned skin.
• Treatment of benign pigmented lesions.
• Treatment of wrinkles.
• Photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
The Alex+Nd:YAG (755 + 1064 lasers) is intended for:
• Stable long-term or permanent hair reduction through selecting targeting of melanin in hair follicles. 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.

Intended Use

The Nd:YAG 1064 Laser is intended for: • Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of Pseudofolliculitis Barbae (PFB). 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. The lasers are indicated on all skin types, such as Fitzpatrick I-VI, including tanned skin. • Photocoagulation and hemostasis of benign pigmented and vascular lesions such as but not limited to port-wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. • Coagulation and hemostasis of soft tissue. • Treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sunspots cafè au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis), tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with benign lesions that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments. • Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. • Treatment of wrinkles. • Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.). The Alexandrite 755 laser is intended for: • Temporary hair reduction. • Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. 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. On all skin types, such as Fitzpatrick I – VI, including tanned skin. • Treatment of benign pigmented lesions. • Treatment of wrinkles. • Photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). The Alex+Nd:YAG (755 + 1064 lasers) is intended for: • Stable long-term or permanent hair reduction through selecting targeting of melanin in hair follicles. 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 complet

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