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The Profound Matrix System is intended for dermatological procedures, as follows: The Matrix Pro applicator is indicated for general dermatological procedures for electrocoagulation and hemostasis. The Matrix Pro applicator is indicated for the percutaneous treatment of facial wrinkles in patients with Fitzpatrick Skin Types I-IV. The Sublative RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62mJ/pin, the Sublative RF applicator is limited to Fitzpatrick Skin Types I-IV. The Sublime applicator is indicated for non-invasive wrinkle treatment. At higher energy levels, greater than 100 J/cm³, the Sublime applicator is limited to Fitzpatrick Skin Types I-IV.

Profound Matrix is a system that combines three existing technologies and applications for dermatological procedures. Each respective technology is used in one of the three applicators designed for the Profound Matrix System. These three applicators are named: Matrix Pro, Sublative RF and Sublime. The system console consists of a CPU, power supply, RF pulse generator, I/O board, splitter/distribution board and footswitch board. When the system is powered up, the user can select between user mode and service/maintenance mode. After selecting user mode and entering the required password, the user is requested to choose between the Matrix Pro, the Sublative RF or the Sublime applicators. Only one applicator can be used to treat a patient at any given time. The user interfaces with the Profound Matrix System and applicators' settings through the 15″ touch screen. Each of the applicators have a finger trigger that can be used to activate the applicator or alternatively the end user can use the footswitch to activate the applicator. Matrix Pro: The Matrix Pro applicator is designed to deliver bipolar, non-ablative radiofrequency energy through a 7x7 matrix/grid of sterile microneedles to the skin in a fractional manner. The microneedles can be set up to pulse up to a maximum of three depths during each insertion of the matrix/grid of microneedles with a maximum depth of up to 3.5mm. The Matrix Pro applicator delivers the right amount of energy at the precise depth, every time. The technology of the Matrix Pro applicator combines adjustable depth, energy, and real time impedance monitoring for customizable and consistent results. The Profound Matrix system monitors tissue impedance across the 3 modalities, in real-time, while simultaneously adjusting RF energy pulse duration and power output. The result is an accurate dose of RF energy delivery with every treatment application for consistent treatment outcomes, independent of patient-to-patient, body location, skin hydration, and procedural-related impedance variations. Sublative RF: The Sublative RF applicator delivers bipolar radiofrequency (RF) to the skin surface in a fractional manner via an array of multi-electrode pin tips, which results in heating of both the demarcated spots to temperatures that ablate and resurface at contact points of the multi-electrode pins while also delivering heat in a wide diffuse manner to the dermis. Sublime: The Sublime applicator uses a combination of an infrared (IR) light source and bipolar radiofrequency (RF) to bulk heat the dermis and affect dermal collagen in order to treat wrinkles. The bulk heating of the dermal layers refers to the gradual and gentle accumulation of heat with each additional pass performed.

Vbeam Prima is indicated for the following: 595 nm - General Surgery: - Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions. - Dermatology/Plastic Surgery: o For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars. striae and Psoriasis and the treatment of wrinkles. - Treatment of Benign Epidermal Pigmented Lesions. - Treatment of Inflammatory Acne Vulgaris. - Gynecology: o Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology. - Podiatry: o Treatment of benign cutaneous lesions, such as warts. - Pediatric Population o Treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas 1064 nm The Vbeam Prima laser system is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, Venus lakes, leg veins, and poikiloderma of Civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), café-au-lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, peri-ocular and peri-oral wrinkles. Vbeam Perfecta is indicated for the following: 595 nm - General Surgery: - Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions. - Dermatology/Plastic Surgery: o For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and Psoriasis and the treatment of wrinkles. - Treatment of Benign Epidermal Pigmented Lesions. - Treatment of Inflammatory Acne Vulgaris. - Gynecology: o Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology. - Podiatry: o Treatment of benign cutaneous lesions, such as warts. - Pediatric Population Treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas

The Candela Vbeam Family of Pulsed Dye Lasers includes both the Vbeam Prima and Vbeam Perfecta Laser Systems. The Vbeam Prima Laser System has been previously cleared for both port wine stains, and hemangiomas under K183452. The Vbeam Perfecta (Candela Family of Pulse Laser Systems) has been previously cleared for both port wine stains, and hemangiomas under K050673. This 510(k) Premarket Notification is to expand the indications for use for the Candela Vbeam Family of Pulsed Dye Lasers for the Vbeam Prima Laser System and Vbeam Perfecta to include the pediatric population for treatment of cutaneous capillary malformations, also known as port wine stains (PWS), and infantile hemangiomas (IH) / congenital hemangiomas for the 595 nm wavelength. There is no new technology being introduced than what has been previously cleared Vbeam Prima Laser System under its predicate K183452 and Vbeam Perfecta under its predicate K050673.

The PicoWay laser system is indicated for the following at the specified wavelength: - · 532 mm: Removal of tattoos for Fitzpatrick Skin Types I-III to treat the following tattoo colors: red, yellow and orange. - · 730 nm: Removal of tattoos for Fitzpatrick Skin Types II-IV to treat the following tattoo colors: green and blue. - · 785 mm: Removal of tattoos for Fitzpatrick Skin Types II-IV to treat the following tattoo colors: green and blue. · 1064 nm: Removal of tattoos for all Fitzpatrick Skin Types to treat the following tattoo colors: black, brown, green, blue and purple. The Pico Way laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V and for treatment of Melasma for Fitzpatrick Skin Types I-IV. The Resolve handpieces (532 nm, and 1064 nm) are also indicated for the treatment of wrinkles in Fitzpatrick Skin Types I-IV. The Resolve Fusion handpiece (532 nm) is indicated for benign pigmented for Fitzpatrick Skin Types I-IV. The PicoWay laser system is indicated for the following at the specified wavelengths: 532 nm : · Treatment of Melasma for Fitzpatrick Skin Types I-IV. · Treatment of café au lait macules (CALMs) for Fitzpatrick Skin Types I-IV. - · Treatment of Lentigines for Fitzpatrick Skin Types I-IV. 730 nm: · Treatment of Lentigines for Fitzpatrick Skin Types I-IV. 1064 nm: - · Treatment of Melasma for Fitzpatrick Skin Types I-IV. - · Treatment of Nevus of Ota for Fitzpatrick Skin Types III-IV.

The PicoWay Laser System is a solid-state laser capable of delivering energy at wavelengths of 1064 nm, 532 nm, or 730 nm, at extremely short duration in the range of 240-500 (ps). The laser system contains one 755 nm (Alexandrite) laser head which is used to 'pump' (create) the 1064 / 532nm wavelengths. The outputs of the two lasers are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532nm or 1064nm wavelengths. The 532nm or 1064nm output energy is delivered to the skin through an Articulated Arm and Zoom Handpiece (HP) delivery system. There are also 3 hand pieces (Resolve), one for 1064nm and two for 532nm (low energy and high energy), which deliver a 10 x 10 array of focused spots to the skin and 1 Axicon hand piece (Resolve Fusion) for 532nm, which delivers a 10 x 10 array of focused and ring spots to the skin.

Nordlys system is intended to be used in dermatology as listed below: Nordlys System + Intense pulse light applicators: * Permanent Hair Reduction (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) (overall 600 - 950 nm). * Treatment of Telangiectasias (530-750 nm or 555-950 nm) * Treatment of Port Wine Stains (530-750 nm or 555-950 nm) * Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation. Ephelides) and Benign Vascular Lesions (ex Diffiuse Redness) (530-750 nm or 555-950 nm) * Treatment of Rosacea (530-750 nm or 555-950 nm) * Treatment of Poikiloderma of Civatte (530-750 nm or 555-950 nm) * Treatment of Benign Epidermal Pigmented Lesions (eg Solar Lentigines ) (400-720 nm) * Treatment of Inflammatory Acne Vulgaris (530-750 nm) Nordlys System + Nd: Y AG Laser (1064 nm): *Treatment of Leg Vessels (0.1-3.0 mm diameter). * Treatment of Benign Vascular Lesions. * Treatment of Venous Lakes. * Treatment of Port Wine Stains. * Treatment for Clear Nail defined as: Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.). * Treatment of benign cutaneous lesions, such as warts. Podiatry (ablation, vaporization, incision, and coagulation of soft tissue), including: - Matrixectomy - Periungal and subungal warts - Plantar warts. Nordlys System + Frax 1940 Laser (1940 nm): * The Frax 1940 is indicated for use in dermatological procedures requiring the coagulation of soft tissue and for skin resurfacing procedures. Frax 1940 is indicated for treatment of benign pigmented lesions, such as but not limited to lentigines (age spots), solar lentigines (sunspots), and ephelides (freckles) for Fitzpatrick Skin Types I-IV. Nordlys System + Frax 1550 Laser (1550 nm): * The Frax 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. Frax Pro system (Y dun) is intended to be used in dermatology, as listed below: Frax Pro System + Frax 1940 (1940 nm) *The Frax 1940nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures. Frax 1940 is indicated for treatment of benign pigmented lesions, such as but not limited to lentigines (age spots), solar lentigines (sunspots), and ephelides (freckles) for Fitzpatrick Skin Types I-IV. Frax Pro System + Frax 1550 (1550 nm) *The Frax 1550nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.

The Frax 1940 applicator is used with the Nordlys and Frax Pro system (previous called Ydun). The Nordlys and Frax Pro systems consist of a console containing power unit and control electronics with control and display panel, including software. The Frax 1940 applicator connects to the systems and has built in Laser diodes emitting 1940 nm light in a fractional pattern.

The PROFOUND MATRIX SYSTEM is intended for dermatological procedures, as follows: The MATRIX PRO applicator is indicated for general dermatological procedures for electrocoagulation and hemostasis. The SUBLATIVE RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62mJ/pin, the Sublative RF applicator is limited to Fitzpatrick Skin Types I-IV. The SUBLIME applicator is indicated for non-invasive wrinkle treatment. At higher energy levels, greater than 100 J/ cm3, the Sublime applicator is limited to Fitzpatrick Skin Types I-IV.

The Profound Matrix System combines three existing technologies and applications for dermatological procedures. Each respective technology is used in one of the three applicators designed for the Profound Matrix System. These three applicators are named: Matrix Pro, Sublative RF and Sublime. The Matrix Pro applicator is designed to deliver bipolar, non-ablative radiofrequency energy through a 7x7 matrix/grid of sterile microneedles to the skin in a fractional manner. The microneedles can be set up to pulse a maximum of three depths during each insertion of the matrix/grid of microneedles with a maximum depth of up to 3.5mm. The Sublative RF applicator delivers bipolar radiofrequency (RF) to the skin surface viaan array of multi-electrode pin tips. The applicator delivers bipolar RF energy to the skin, which results in heating of demarcated spots to temperatures that ablate and resurface at contact points of the multi-electrode pins. The Sublime applicator uses a combination of an infrared (IR) light source and bipolar radiofrequency (RF) to bulk heat the dermis and affect dermal collagen in order to treat wrinkles. The bulk heating of the dermal layers refers to the gradual and gentle accumulation of heat with each additional pass performed.

755mm: Temporary hair reduction. Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas). 1064nm: Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment 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 pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for pigmented 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. 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/or yeast Candida Albicans, etc.)

The GentleMax Pro Plus contains two separate laser heads (Alexandrite and Nd:YAG), which produce laser light outputs of 755 nm and 1064 nm, respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen.

The PicoWay laser system is indicated for the following at the specified wavelength: 532 nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. 730 nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. 785 nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. The Resolve handpieces (532 nm HE, 532 nm, 1064 nm) are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV The Resolve Fusion handpiece (1064 nm) is indicated for the treatment of wrinkles as well as benign pigmented lessons in Fitzpatrick Skin Types I-IV The Resolve Fusion handpiece (532 nm) is indicated for the treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV

The PicoWay System has been previously cleared (K170597, K162454, K160607, K150326, K142372 and K153527) for tattoo removal and treatment/removal of benign pigmented lesions as well as treatment of acne scars and wrinkles. There are minor modifications to the current system to add four (4) new handpieces, minor system specifications, and new wavelengths. The additional new handpieces will work in the same way as the currently cleared PicoWay handpieces as in they will operate in the same manner as the predicate devices. The PicoWay Laser System is a solid-state laser capable of delivering energy at wavelengths of 1064 nm, 532 nm, 730 nm (new) or 785 nm at extremely short duration in the range of 240-500 ps. The laser system contains one 755 nm (Alexandrite) laser head which is used to 'pump' (create) the 1064 nm picosecond wavelength. The 1064 nm wavelength can be frequency-doubled to 532 nm as desired. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532 nm or 1064 nm wavelengths. The current 785 nm and new 730 nm wavelength contain a Ti:Sapphire laser rod that is pumped with the 532 nm energy. All these energies are delivered through an articulated arm and corresponding handpiece. Currently there are two cleared Resolve handpieces (1064 nm and 532 nm), a 785 nm handpiece and a Zoom handpiece that works on two wavelengths (532 nm and 1064 nm).

The PicoWay laser system is indicated for the following at the specified wavelength: 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. 785nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. The Resolve handpieces are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.

The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm, 785 nm, or 532 nm at short durations of 240–750 picoseconds (ps) at repetition rates up to 10 Hz (1064 nm, 532 nm) or 5 Hz (785 nm). The device system is comprised of a system console, an articulated arm, and an attached handpiece. The laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system terminated by a handpiece. The light-weight and ergonomic handpieces allow the spot size on the skin to be easily adjusted. A range of spot sizes is available for the PicoWay System (up to 10 mm). The system includes an internal calibration port with an internal meter located on the control panel of the system console, which is used to verify the transmission of the articulated arm. The PicoWay system control panel enables the user to select the desired energy density level and repetition rate. The control panel is also used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

The PicoWay laser system is indicated for the following at the specified wavelength: 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. 785nm: Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.

The PicoWay Laser System is a solid state laser capable of delivering energy at wavelengths of 1064 nm, 785 nm, or 532 nm at short durations of 240-540 picoseconds (ps) at repetition rates up to 10 Hz (1064 nm, 532 nm) or 5 Hz (785 nm). The device system is comprised of a system console, an articulated arm, and an attached Zoom or Resolve Handpiece. The laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system terminated by a Handpiece. The light-weight and ergonomic Zoom Handpieces allow the spot size on the skin to be easily adjusted. A range of spot sizes is available for the PicoWay System when using the Zoom Handpiece (up to 10 mm). The Resolve Handpieces are available with 6 x 6 mm spot size for both wavelengths. The system includes an internal calibration port with an internal meter located on the control panel of the system console, which is used to verify the transmission of the laser beam into the articulated arm. The PicoWay system control panel enables the user to select the desired energy density level and repetition rate. The control panel is also used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

The Profound System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Specifically, the 25º Dermal handpiece and cartidge are used for percutaneous treatment of facial wrinkles, and the 75° SubQ handpiece and cartridge are used to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III as supported by long-term clinical data (6 months).

The Profound System is comprised of the following components: a re-usable console containing a radiofrequency (RF) generator and graphical user interface; two re-usable treatment applicators; and two disposable, single use, sterile electrode cartridges. Bipolar RF energy is delivered from the RF generator through the electrodes into the dermal layers beneath the surface of the skin. The volume of the treated area is defined by the geometry of the individual micro-electrode needle pairs, which are all electrically isolated from each other and controlled independently by separated RF channels within the console. In addition, temperature sensors provide real-time feedback of tissue temperature. The treatment dose is controlled by the physician.