Manufacturer
Bios S.R.L.Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
Country / Region:Italy (IT)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K243445
- Device name
- Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
- Company
- Bios S.R.L.
- 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
Summary parsed at:2026-06-01 05:29:42 UTC
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