Omnimax S3, Omnimax S4

The Omnimax Device Series along with its optional Handpieces, uses IPL, IR, Laser and RF technologies and is intended for use in aesthetic and cosmetic applications and in selective treatments in medical specialties of dermatology, through the transmission of energy to human skin.

Intense Pulsed Light (IPL-DPC) with 415 – 1200 nm wavelengths (with and without contact-cooling) handpieces are indicated for:
* Hair removal and Permanent Hair Reduction in all skin types (I-V) to the Fitzpatrick scale - Recommended wavelengths in the range of 635-950 nm, 730-950 nm or 580-950 nm.
* Flow Mode is suitable for Fitzpatrick skin types I-VI. Recommended wavelength: 635nm-950nm.
* 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 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 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.
* Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale – Recommended wavelength in the range of 415-950 nm.

Infrared (IR) with 850 – 1750 nm wavelengths (with contact cooling) handpieces is indicated for:
* Dermatologic Treatment such as, but not limited to: photocoagulation of soft tissue (Scars, Wrinkles, Rhytids and Periorbital Wrinkles).

Radio Frequency (RF) handpieces are indicated for:
* Treatment of mild to moderate facial wrinkles and rhytids for all skin types.

Nd:YAG Laser 1064 nm Long Pulse (LP) handpiece 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.
* Treatment of pseudofolliculitis barbae (PFB).
* 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; 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 resurf

The Omnimax Device Series along with its optional Handpieces, uses IPL, IR, Laser and RF technologies and is intended for use in aesthetic and cosmetic applications and in selective treatments in medical specialties of dermatology, through the transmission of energy to human skin.

The Omnimax Device Series, which includes the Omnimax S3 and S4 devices, is a multi-application, multi-technology platform designed for skin treatments and various aesthetic and dermatological applications. This is achieved by applying light energy (IPL, IR, and Laser) and Radio Frequency (RF) to the human skin. Each device in the series features the following technologies: The Omnimax S4 incorporates IPL-DPC, IR, RF, and Laser technologies. The Omnimax S3 incorporates IPL-DPC, IR, and RF technologies. The Omnimax Device Series modification enhances capabilities of the legally cleared Dermatological Treatment Device Family (K111303) by adding RF functionality with optional handpieces in addition to the previously cleared IPL, Laser and IR technology. The system consists of: a) Main unit (includes controller) b) Control Panel (UI) c) RF Module d) Display Unit e) Footswitch f) Trolley g) 14 Handpieces/applicators: • IPL-DPC – 7 Handpieces • IR – 2 Handpieces • Laser – 3 Handpieces • RF – 2 Handpieces The main unit is a platform system with embedded software, designed to support all treatment technologies and handpieces (i.e. IPL-DPC, IR, Laser and RF).