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Rapid Family systems and optional Hand-Pieces are intended for use in aesthetic and cosmetic applications and in selective treatments required in the medical specialties of dermatology. Rapid Family systems and optional Hand-pieces with 420 – 1200 nm wavelengths (with and without contact-cooling) are indicated for: * Hair removal and Permanent Hair Reduction in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelengths in the range of 635-950 nm, 730-950 nm or 580-950 nm * Treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm * Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale – Recommended wavelength in the range of 420-950 nm * Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 580-950 nm * Treatment of Benign Pigmented Epidermal, Cutaneous and Vascular Lesions including warts; scars and striae in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-680 nm & 860-1200nm Rapid Family systems and optional Infrared (IR) Hand Pieces with 850 - 1750 nm wavelengths (with contact cooling) are indicated for: * Dermatologic Treatment such as, but not limited to: photocoagulation of soft tissue (Scars, Wrinkles, Rhytids and Periorbital Wrinkles) Rapid Family systems and optional Nd: YAG Laser 1064 nm Long Pulse (LP) Hand-Pieces are indicated for: * Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. * Removal or lightening of unwanted hair (with and without adjuvant preparation) * Treatment of pseudofolliculitis barbae (PFB) Rapid Family systems and optional Nd:YAG Laser 1064 nm Long Pulse (LP) and Q-Switched Hand-Pieces are indicated for: * 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; Sebortheic; 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 blue/black tattoos); Plaques * 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. * The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles Rapid Family systems and optional Nd:YAG Laser 1064 nm Long Pulse (LP) and Q-Switched Hand-Pieces are indicated for: * 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. Rapid Family systems and optional Nd: YAG Laser 532 nm Frequency Dabbler (FD) Long Pulse (LP) and O-Switched Hand-Pieces are indicated for: * Tattoo removal: Light blue; Yellow; Red; Green * Vascular lesions: Hemangiomas (Port wine stains/birthmarks, cavernous, cherry, spider); hemangiomas; Angiomas (cherry, spider); Telangiectasia; Spider nevi * Benign pigmented lesions, such as, but not limited to: Cafe-au-lait (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevi; Nevus spillus, Nevus of Ota; Becker's Nevi; * Other pigmented cutaneous lesions, such as, but not limited to: Verrucae; Skin tags; Plaques Rapid Family systems and optional Er: Y AG Laser 2940 nm Long Pulse (LP) Hand-Pieces, with standard and scanner accessory tips are indicated for: Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands) such as, but not limited to: * Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins: Actinic chelitis: Keloids: Verrucae: Skin tags: Keratoses: Scar revision (including acne scars) NOTE Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen

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The Dermatological Treatment Systems device family and optional Hand Piece family are intended for use in aesthetic and cosmetic applications and in selective treatments required in the medical specialties of dermatology. The DTS device family is indicated for dermatological treatments such as, but not limited to: * Hair removal in all skin types to the Fitzpatrick scale. Permanent Hair Reduction. * Treatment of Vascular Lesions * Treatment of Inflammatory Acne (acne vulgaris) * Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae. * Treatment of Wrinkles, rhytids and Periorbital Wrinkles * Skin resurfacing (Acne scars) * Treatment of Tattoos * Treatment of Leg and Facial Vein Removal * Treatment of photocoagulation of soft tissue in dermatologic applications * Resurfacing of the skin, and for the treatment of facial wrinkles. The Dermatological Treatment device family and optional Hand pieces with 415 -1200 nm wavelengths (with and without contact-cooling) are indicated for: * Hair removal and Permanent Hair Reduction in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelengths in the range of 635-950 nm, 730-950 nm or 580-950 nm * Treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm * Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 415-950 nm * Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 580-950 nm * Treatment of Benign Pigmented Epidermal, Cutaneous and Vascular Lesions including warts; scars and striae in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-680 nm & 860-1200nm The Dermatological Treatment device family and optional Infrared (IR) Hand Pieces with 850 - 1750 nm wavelengths (with contact cooling) is indicated for: * Dermatologic Treatment such as, but not limited to: photocoagulation of soft tissue (Scars, Wrinkles, Rhytids and Periorbital Wrinkles) The Dermatological Treatment device family and optional Nd: YAG Laser 1064 nm Long Pulse (LP) Hand Pieces is indicated for: * Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. * Removal or lightening of unwanted hair (with and without adjuvant preparation) * Treatment of pseudofolliculitis barbae (PFB) The Dermatological Treatment device family and optional Nd:YAG Laser 1064 nm Long Pulse (LP) and Q-Switched Hand Pieces is indicated for: * 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 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 Dermatological Treatment device family and optional Nd:YAG Laser 532 mm Frequency Dabbler (FD) Long Pulse (LP) and Q-Switched Hand Pieces is indicated for: * Tattoo removal: Light blue; Yellow; Red; Green * Vascular lesions: Hemangiomas (Port wine stains/birthmarks, cavernous, cherry, spider); hemangiomas; Angiomas (cherry, spider); Telangiectasia; Spider nevi * Benign pigmented lesions, such as, but not limited to: Cafe-au-lait (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevi; Nevus spillus, Nevus of Ota: Becker's Nevi; * Other pigmented cutaneous lesions, such as, but not limited to: Verrucae; Skin tags; Keratoses; Plaques The Dermatological Treatment device family and optional Er:YAG Laser 2940 nm Long Pulse (LP) Hand Pieces, with standard and scanner accessory tips is indicated for: Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands) such as, but not limited to: * Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars);

The Dermatologic Treatment Systems (DTS) device family and optional hand pieces, including Intensive Pulse Light (IPL) Infrared light (IR) and Laser light technologies for dermatological treatments by delivery of energy to the human skin. The device family is a modification to the BeaMax/ ForMax family (K082876), pulsed light energy device based on a filtered, Xenon flashlamp. The DTS device family modification enhances capabilities of the legally cleared Beamax/ Formax device family by adding new hand pieces that are now supporting Laser and IR technologies as well as the IPL technology. The Basic unit is a platform system, designed to support all treatment technologies hand pieces (i.e. IPL, IR and Laser). The embedded software is the heart of the control system which provides a control of all of the parameters to the relevant hand piece, where the operator has the access to modify some parameters via the touch screen and every hand piece has its own operating screen.

The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family are intended for use in aesthetic and cosmetic applications and in selective treatments required in the medical specialties of dermatology. The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family with 415 - 950 nm wavelengths (with and without contact-cooling) are indicated for: - Hair removal in all skin types (I-VI) to the Fitzpatrick scale. Permanent Hair Reduction. - Recommended wavelengths in the range of 635-950 nm or 580-950 nm - Treatment of Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale -Recommended wavelength in the range of 535-950 nm - Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm - Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 415-950 nm

The proposed BEAMAX/ FORMAX family system is a pulsed light energy device based on a filtered, Xenon flashlamp. The total emission spectrum of a Xenon flashlamp is from around 300 nm in the UV to 1000 nm in the near IR. The light emitted from the lamp is collected by a reflector and focused into a rectangular, waveguide. Prior to entering the waveguide, the light is transmitted through a longpass optical filter which blocks all wavelengths below the "cut-off" wavelength of the filter. Thus when a 635nm filter is used, only light of wavelengths above 635 nm is emitted. Since the lamp is surrounded by a water cooling jacket, actual wavelength emission is up to about 950 nm, due to water absorption of longer wavelengths. The BEAMAX/FORMAX family system is equipped with four different handpieces which can be attached for different clinical applications. These handpieces differ in the optical filter applied, hence in the optical spectrum emitted, as well as in the time duration of the pulses emitted. A microprocessor based system controller is used to monitor and direct all system functions and Man Machine Interface.