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The E-PEN is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older.

The E-PEN is a microneedling device that mechanically creates microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The E-PEN is comprised of a reusable pen body, a sterile, single use microneedling cartridge, and a power adapter. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetration can be adjusted by the user depending on the condition of the skin being treated. Charging is accomplished by attaching the E-PEN pen body to the power adapter.

The 1NEED Pro is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older.

The 1NEED Pro is a minimally invasive microneedling device that microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The 1NEED Pro is comprised of a reusable pen body, a sterile, single use microneedling cartridge and a power adapter. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetration can be adjusted by the user depending of the skin being treated. Charging is accomplished by attaching the 1NEED Pro pen body to the power adapter.

The XCELLARISPRO TWIST microneedling device and accessories is intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I. II, III and IV in adults aged 22 years or older and for treatment of wrinkles in Fitzpatrick skin types I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.

The XCELLARISPRO TWIST is a microneedling device and intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainlesssteel needles. The XCELLARISPRO TWIST has 4 component parts and 2 consumables. Component parts: (1) handpiece, (2) control unit, (3) power supply and (4) foot switch. Consumables: (1) sterile, single-use needling module (Ethylene oxide sterilized) and (2) disposable barrier sleeves that cover the handpiece during each patient use.

The SER Pen Carain MicroSystem is intended for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older and as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.

The SER Pen Carain MicroSystem (MP1209SP) is a handheld device that creates channels as well as microinjuries into the skin, by virtue of a DC motor drive system that rapidly reciprocates an array of 12 needles and 36 needles that are no longer than 2.5mm. The device consists of a power source, a motor body with depth adjustment, and a disposable, single use cartridge containing an array of needles. The power source consists of a rechargeable lithium-ion battery that delivers no more than 5 volts DC and 1 amp of current to power the motor. A power cord connects the wall adaptor to the device via a USB connector and a standard 1/8" headphone plug on the device side. The motor body is comprised of anodized aluminum with a dial mechanism that controls the depth of penetration of the microneedles from 0.0 mm to a maximum of 2.5mm. The SER Pen Carain MicroSystem's disposable cartridge is designed in two configurations, a 12-needle array and a 36-needle array. The needle array is housed in a specially designed cartridge housing with a silicon spring that prevents liquids from entering the motor body via the inside lumen of the cartridge. The SER Pen Carain MicroSystem biolock sleeve is a one end elastic opening PE bag to protect the whole system from cross contamination from the outside during the operation procedure. The SER Pen Carain MicroSystem microneedles are composed of 304 18/8 surgical steel tested and certified as biocompatible under GLP testing conditions that conform to ISO 10993-5, 10993-10, and 10993-11. A metallurgical analysis under GLP testing conditions that conform to ASTM E1019-11(Method A)(C/S Analyzer) was also completed and is attached. Each lot of cartridges are individually packaged and then gamma ray sterilized by TUV Sud accredited facility under procedure code P1501314 with a minimum dose of 25kGy. Certifications on file with the Sponsor and available for review.

The SkinPen® Precision Elite system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 vears and older.

The SkinPen® Precision Elite System consists of a microneedling pen handpiece (SkinPen® Precision Elite) and a sterile needle cartridge (SkinPen® Precision Elite Cartridge). The accessories are a charging base with power adaptor and a BioSheath to cover the handpiece.

The Exceed Unlimited is a microneedling device and accessories intended for the treatment of wrinkles in Fitzpatrick skin types I. Il and/or III in the following facial areas: qlabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older. The Exceed Unlimited is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, III and IV in adults aged 22 years or older.

The Exceed Unlimited device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles. The Exceed Unlimited device consists of 7 component parts; Handpiece, sterile single use Safety needle cartridge, Handpiece holder, Barrier Sleeve, Battery, Charger incl. USB cable, power supply. The handpiece contains a motor that moves the needles. The handpiece receives power via a Li-Ion battery with an output of 3,7 V. The battery charger receives power from a standard 100-240V, 50-60Hz, 0.45A wall socket transformer with an USB output of 5 V, 3.2A. The frequency of the handpiece can be adjusted from 100-150Hz and is indicated on a display. The needle penetration is adjusted by the needle protrusion setting dial, which can be adjusted between 0.0 (min.) and 1.9 mm (max.). The standard safety needle cartridge (6-needle plate) contains 6 stainless steel microneedles of 1.5 mm length (0.35 mm gauge) and an internal safety membrane. The safety needle cartridge is screwed into the handpiece. The safety needle cartridge is sterile and for single use ONLY.

The Dr.pen Microneedling System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older.

The Dr.pen Microneedling System is a minimally invasive microneedling device that mechanically creates microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The Dr. pen Microneedling System is comprised of a reusable pen body, a sterile, single use microneedling cartridge, a power adapter, and a disposible protective sleeve. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetration can be adjusted by the user depending on the condition of the skin being treated. Charging is accomplished by attaching the Dr.pen pen body to the power adapter.

The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older. The SkinStylus SteriLock® MicroSystem is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, and III in patients aged 22 years and older.

The SkinStylus SteriLock® MicroSystem is a handheld device that creates channels as well as microinjuries into the skin, by virtue of a 1A DC motor that rapidly reciprocates an array of 32 gauge microneedles that are no longer than 2.5mm. The device consists of a power source, a motor body with depth adjustment, a removable nosecone interface, and a disposable, single use cartridge containing an array of microneedles. The power source consists of two separate systems. One option is a rechargeable lithium-ion battery that delivers no more than 5 volts DC and 1 amp of current to power the motor. The other option consists of an AC wall adaptor that converts 110v AC into 5v DC. A power cord connects the wall adaptor to the device via a USB connector and a standard 1/8" headphone plug on the device side. The motor body is comprised of anodized aluminum with a dial mechanism that controls the depth of penetration of the microneedles from 0.0 mm to a maximum of 2.5mm. The removable nosecone interface provides the SkinStylus® the unique ability to have an interface between the motor and the cartridge to ensure there is a secondary control preventing any fluid from entering the motor body. The removable nosecone is autoclave sterilized after every use. The SkinStylus® disposable cartridge is designed in a 36-needle array with all needles at 2.5mm. The needle array is housed in a specially designed and patented cartridge housing that prevents liquids from entering the motor body via the inside lumen of the cartridge. The SkinStylus SteriLock® microneedles are composed of 304 18/8 surgical steel tested and certified as biocompatible under GLP testing conditions that conform to ISO 10993-10, and 10993-11.

The AI.ME™system is indicated for fractional skin resurfacing.

The AI.ME system is a micro coring device controlled by a robot that removes skin by using a disposable punch assembly containing six (6), hollow needle punches inserted into the skin with a fixed maximum penetration depth of 3 mm to remove up to 10% of skin in the treatment area to excise and/or resurface skin. The AI.ME system, which is similar in design and performance as the FDA cleared Venus Concept ARTAS system, consists of a cart, a coring mechanism, single-use vacuum assembly and a sterile single-use disposable punch assembly.

The DP4 microneedling device is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, III, IV and V in adults aged 22 years or older.

DP4 Microneedling device is a Digital Automated Microneedling system. The DP4 system consists of the following components: - 1. Handpiece - 2. Needle Cartridge - 3. DP4 Sleeve (barrier sleeve) - 4. Battery Charger, 2 Batteries - 5. AC/DC Power Adaptor - 6. Desk Stand - 7. DP4 US™ companion app. The handpiece (1) contains a mains connector, a drive train, a digital display to relay information to the operator an ON/OFF button and 2 separate toggle buttons to adjust frequency and needle depth. The handpiece receives its power via an external AC/DC power adaptor (input Voltage/Current is 100-240VAC, 1.0-0.5A,50-60Hz: Output Voltage/Current: 5V DC, 2.4A) or removable lithium ion battery (3.7 VDC). The battery does not need to be removed to make use of the mains power adaptor. The power adaptor connects to the handpiece via a custom DC connection (over-mold bayonet type). The drive train encompasses a DC motor, eccentric cam and rotational to linear drive converter to oscillate the Cartridge needles. The digital display shows battery status, cartridge status, sync/update notifications and bluetooth connectivity. The display also contains a digital dial to convey frequency or motor speed and a 3figure display showing current needle depth. The frequency of oscillation can be set from 80-110Hz (+/-10 Hz(range 70-120Hz) and the needle depth from 0.2mm to 3mm. The DP4 needle Cartridge (2) is a sterile, single use consumable designed to create micro incisions in the epidermis and dermis. Each cartridge contains 16, 3mm, 33-gauge surgical grade stainless steel needles, arranged in a circular pattern. Each needle cartridge employs a bayonet feature to securely connect it to the handpiece during operation. Internal and external seals assist in the prevention of cross contamination. Each needle Cartridge contains a Radio-frequency identification (RFID) tag encoded with a unique ID and a needle depth correction factor. This information is read from the cartridge when it is first inserted into the handpiece and prevents reuse of the cartridge once the cartridge is removed from the handpiece. The DP4 sleeve (3) is a single use, sterile, biohazard barrier used to prevent contamination of the handpiece by bodily fluids generated during the treatment. It covers the extent of the handpiece, including the intersection between the handpiece and needle Cartridge. The battery charger (4) is capable of charging 1 x 14500 Lithium cell. The system batteries can only be charged when removed from the handpiece and inserted into the battery charger. The desk stand (5) is used for storage of device while not in use. The DP4 US companion app software application (6) is an app. run on a Bluetooth enabled User device to enable the User to interact with the DP4 CRM system. The app contains no patient data and transmits no patient data. The equipment is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat.