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The subject F65 has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows: The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for: - o Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles) - o Cutaneous lesions, including warts, scars and striae - o Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations - o Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles - o Mild to moderate inflammatory Acne (Acne vulgaris) The Nd: YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd: YAG) is indicated for: - o The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg - o The removal of unwanted hair and to effect table long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles - o The non-ablative treatment of facial wrinkles The F65 module and handpiece, with wavelength of 1565 nm, are indicated for: - o Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue - o Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV who are seeking treatment for hair loss. The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for: o Removal of dark tattoos o Treatment of pigmented lesions *Note Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.

The Lumenis Be F65 Laser System is intended to be used for the new indication for Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV seeking treatment for hair loss, as well as, for the identical set of functions as the predicate device. The description here is limited to the system module required to support the new indication which is the subject of this 510(k): - The laser console includes a power supply unit, a Laser module (+ aiming beam), a control unit and a PC module. The laser beam is transferred to the handpiece via fiber optics. - . The handpiece includes a scanner module – built of two mirrors that are controlled by two motors directing the Laser beam to desired target tissue. - . The handpiece uses a tip (user may choose from two types) to align the Laser beam focus with the target tissue, enabling a treatment shape size and a tip thermo-electric cooler (TEC). The F65 is intended for professional use only.

The UltraPulse Alpha CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) are indicated for use in surgical or aesthetic applications requiring: ablation, vaporization, excision, or coagulation of soft tissue in medical specialties including: dermatology and plastic surgery (aesthetic), podiatry , gynecology, general and oral surgery, dental and oral surgery and genitourinary surgery as follows: The UltraPulse SurgiTouch and UltraPulse Encore CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) are indicated for use in surgical or aesthetic applications requiring: ablation, vaporization, excision, or coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery as follows:

The Lumenis Be Family of UltraPulse CO2 Surgical and Aesthetic Laser Systems, Delivery Devices and Accessories (subject devices) consist of the following devices: Laser Systems - o UltraPulse Alpha (also written as UltraPulse α) - UltraPulse Encore o - UltraPulse SurgiTouch o Delivery Devices and Accessories - o DeepFX Microscanner and disposable tips - UltraScan CPG Microscanner o - o TrueSpot 2.0 mm Collimated Handpiece - o 0.2 mm and 1.0 mm Focused Incisional Handpieces (also called Standard Handpieces) Each UltraPulse laser system is an advanced computer-controlled device with RF - modulated CO2 laser tube technology that emits laser beams at a wavelength of 10,600 or 11,100 nm. Each has an additional diode laser in the red visible spectrum emitting along the same optical path as the CO2 to serve as an aiming beam. Attached to each laser system are the delivery devices and accessories that direct the laser beams to the intended treatment site in the format as selected by the user.