Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Nd:Yag 1064 Laser is intended for: - Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of 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 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 (sun spots), 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. The Nd:Yag 1064 Laser is intended for: - 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 (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 Nd:Yag 1064 Laser is intended for: - Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of 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 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 (sun spots), 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. The Nd:Yag 1064 Laser is intended for: - 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 (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 FAMILY OF SQUARE EPIL LASER is a laser equipped with one or two solid-state laser sources: The 4 configurations of the Family differ for the internal crystals of the sources, that can be Alexandrite and/or Nd:YAG. The emitted laser radiation has a wavelength of 755nm, respectively, and 1064nm: - Alex configuration has only one source and one wavelength available (755 nm). - Alex2 configuration has two sources of the same wavelength (755 nm), in order to increase the maximum power available. - Nd:Yag configuration has only one source and one wavelength available (1064 nm). - In the Alex+Nd:Yag configuration has both the two wavelengths available (755 nm and 1064 nm) but can act only individually, simultaneous operations are not allowed. This device is intended for medical use only.
Summary parsed at:2026-06-01 06:06:28 UTC
