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The Nd: YAG Laser Therapy Systems is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology, as follows:

532nm wavelength:

• Removal of light ink (red, sky blue, green, purple, and orange) tattoo.
• Treatment of benign vascular lesions including, but not limited to: telangiectasias.
• Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi, freckles, Nevus spilus, Seborrheic Keratoses.
• Treatment of Post Inflammatory Hyper-Pigmentation.

1064nm wavelength:

• Removal dark ink (black, blue and brown) tattoo.
• Removal of benign dermal pigmented lesions including, but not limited to: Nevus of Ota, Common Nevi, and Melasma.
• Removal or lightening of unwanted hair with or without adjuvant preparation.
• Skin resurfacing procedures for the treatment of acne scars and wrinkles.

The design and production of the Nd: YAG Laser Therapy Systems fully comply with the relevant national safety standards and quality standards for laser medical equipment testing requirements, and has reached the international advanced level. This machine adopts advanced optical technology and accessories. A multifunctional microcomputer can control and adjust the size of the laser spot,making it suitable for treating diseases in different parts of the body.

The Nd: YAG Laser Therapy Systems is a kind of laser pigment treatment instrument. It uses the principle of "photo-blasting". The laser emits high energy instantaneously, causing the pigment particles to absorb the laser energy and rapidly expand and rupture. Part of the pigment is broken down into smaller particles and excreted from the body, and the other part is swallowed by human macrophages and excreted through the lymphatic system.

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The CO2 Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

The working principle of CO2 laser system instrument is that the laser power supply drives the laser emitter to emit light, through the refraction of several mirrors, the light is transmitted to the treatment head, and then the light is aggregated into one point by the focusing mirror, which can reach a very high temperature, so that the treatment area can be sublimated into gas in an instant, so as to achieve the purpose of treatment.

The CO2 laser system comprises essential components including the main unit, treatment handpiece, foot switch, and various accessories. The wavelength of CO2 laser system is 10600nm.

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The LED Light Therapy Mask is an Over-the-Counter (OTC) device intended for treatment of fine lines and wrinkles, and increase in circulation within the perioral region.

LED Light Therapy Mask is a home use device. LED Light Therapy Mask - LumiLips FAC07NA uses Light Emitting Diode (LED) energy to treatment of fine lines and wrinkles and increase in circulation within the perioral region. There are 4 kinds of light which include Red light (wavelength 630nm), Dark red light (wavelength 660nm), Near-Infrared light (wavelength 880nm), Amber light (wavelength 605nm).

There is only one model of LED Light Therapy Mask: LumiLips FAC07NA. The product consists of LED lip mask, Mouthpiece, charging cable. The mouthpiece can be removable.

The application area of LumiLips FAC07NA is the lips and surrounding area.

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(1) The CureLight Medical Diode Laser Systems, include model: CureLight F2-A15 and CureLight F2-A30, are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.

(2) The CureLight Medical Diode Laser Systems, model: CureLight F2-B15, CureLight F2-B30, CureLight F3-AB30 and CureLight F3-AB60 are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.

The CureLight Medical Diode Laser Systems, model: CureLight F2-B15, CureLight F2-B30, CureLight F3-AB30 and CureLight F3-AB60 are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

The "CureLight Medical Diode Laser Systems", include model: CureLight F2-A15, CureLight F2-A30, CureLight F2-B15, CureLight F2-B30, CureLight F3-AB30 and CureLight F3-AB60. Which consist of three main components:

(1) Main device;
(2) Foot switch;
(3) Accessories.

Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.

The diode laser for this unit is GaAlAs diode bar, and the wavelength is 810/980nm. It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the PHOMED'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber.

MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system. It supplies power for MCU, diode laser module by DC-DC conversion module and temp system by temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.

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The LASER THERMAL THERAPY KIT is used to direct laser energy to soft tissue, to vaporize, ablate, necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064nm.

The LASER THERMAL THERAPY KIT is used to transfer laser energy from the laser unit to the tissue site for the treatment. The energy is transmitted via the fiber optic, which is introduced into the skin and tissue site percutaneously using the introducer needle. The LASER THERMAL THERAPY KIT is composed of a Fiber Optic for PLA (272 m core quartz-quartz fiber with distal end outer diameter 420 m and NA 0.2, and 2 m length) and an introducer needle (21G). The device is sterile and single use. Fiber optic and Introducer are packed individually.

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The Elyra™ TFL System (Laser, Fibers, and Accessories) is intended for incision, excision, resection, ablation, coagulation and hemostasis of soft tissue, with or without an endoscope, in the following indications: urology and lithotripsy.

Urology

• Condylomas
• Urethral strictures
• Lesions of external genitalia
• Bladder neck incisions (BNI)
• Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
• Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
• Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy

• Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate monohydrate, and calcium oxalate dihydrate stones
• Endoscopic fragmentation of calculi
• Treatment of distal impacted fragments of steinstrasse when guidewire cannot be passed

Elyra™ Plus Thulium Fiber Laser System

The Elyra™ Plus TFL System (Laser, Fibers, and Accessories) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology and lithotripsy.

Urology

• Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
• Laser Resection of the Prostrate (LRP)
• Laser Enucleation of the Prostate (LEP)
• Laser Ablation of the Prostate (LAP)
• Transurethral Incision of the Prostate (TUIP)
• Condylomas
• Urethral strictures
• Lesions of external genitalia
• Bladder neck incisions (BNI)
• Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
• Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
• Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy Indications

• Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate monohydrate, and calcium oxalate dihydrate stones
• Endoscopic fragmentation of calculi
• Treatment of distal impacted fragments of steinstrasse when guidewire cannot be passed

The Elyra™ Thulium Fiber Laser (TFL) System (Elyra™ Plus, Elyra™, Elyra™ Thulium Laser Fibers and Accessories) is a thulium fiber laser which delivers a pulsed beam of near-infrared light (1940nm) through the active media of a single use or reusable delivery fiber. The system is contained in a mobile format and has an articulating graphical user interface display and built-in laser generator with the ability to connect to standard mains power.

The Elyra™ TFL System is available in two models: the Elyra™ TFL System and the Elyra™ Plus TFL System. The lasers are similar devices with only the following differences:

• maximum average power output
• frequency
• pulse duration
• pulse energy
• maximum peak power
• foot pedal options to activate energy delivery
• vaporization and BPH indications

The Elyra™ TFL System and Elyra™ Plus TFL System includes a medical laser generator (which includes a blast shield, remote interlock connector, keys, and power cord), delivery fibers, and a footswitch (hybrid or wired). Safety goggles are provided with each system.

The delivery fibers are available in standard tip and ball tip options as single use devices. Reusable fibers are only available in the standard tip option. Each fiber contains a unique radio frequency identification (RFID) tag that will allow the laser generator to identify certain aspects of the fiber, including UDI, catalog number, lot number, manufacture date, expiration date, size, max power and energy, and number of remaining uses (if applicable information once attached). Fibers are only compatible with Elyra™ systems.

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• Red+Infrared light: Treatment of full-face wrinkles.
• Blue light: Treatment of mild to moderate inflammatory acne.
• Mixed light (Red+Blue +Infrared): Treatment of mild to moderate inflammatory acne.

LED Light Therapy Mask (Models: T2, RLD10) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne. LED Light Therapy Mask consists of main unit (mask, safety goggles), controller, Type-C charging cable and straps. There are 3 kinds of light, which include Red light (wavelength 630nm), Blue light (wavelength 470nm), Infrared light (wavelength 850nm). All models can output 3 kinds of treatment modes: red+infrared, blue and red+infrared+blue light.

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Ulike Reglow Light Therapy Device is an over the counter device that is intended for use in the treatment of full face wrinkles and treatment of mild to moderate inflammatory acne.

Ulike Reglow Light Therapy Device adopts 272 light emitting diodes (LED) with the multiwavelength of 630nm±10nm,830nm±10nm,590nm±10nm and 465nm±10nm spectrum to irradiate the facial area to realize its therapeutic effect, including reducing wrinkles and treating mild to moderate inflammatory acne, which improves overall skin appearance.

The Ulike Reglow Light Therapy Device adopts the form of a mask that contains LEDs on the inner surface of the main unit. The device is with user-friendly operation through a controller which is connected to the main unit to control the device, such as turn on/off the device, switch mode.

The device offers four selectable operating modes via the external controller:

• Mode 1 (Glow mode): 630 nm + 830 nm + 590 nm
• Mode 2 (Anti-Aging mode): 630 nm + 830 nm
• Mode 3 (Restoring mode): 590 nm + 830 nm
• Mode 4 (Clear mode): 465 nm + 630 nm + 830 nm

To use the device, user should place the mask over the face and use the controller to operate. To prevent irradiation of LED lights to eyes during the treatment, Ulike Reglow Light Therapy Device has incorporated protective eye-shield which blocks light energy from LEDs.

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The Visualase™ MRI-Guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 800nm through 1064nm lasers.

The Visualase™ V2 MRI-Guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis, and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in pediatrics and adults with 980 nm lasers. The intended patients are adults and pediatric patients from the age of 2 years and older.

The Visualase Cooled Laser Applicator System (VCLAS) is an MR-compatible (conditional), sterile, single-use, saline-cooled laser applicator with proprietary diffusing tips that deliver controlled energy to targeted tissue when connected to the Visualase Systems.

The VCLAS is an accessory to both cleared versions of the Visualase Cooled Laser Ablation Systems - Visualase MRI-guided Laser Ablation System (V1 System, K211269) and Visualase V2 MRI-guided Laser Ablation System (V2 System, K250307). The V1 and V2 systems are not subjects of this submission.

This change encompasses changes to the Visualase Cooled Laser Applicator System (VCLAS) pump tubing set, extension tubing and inlet/outlet ports to ensure compatibility with both cleared Visualase Systems (K211269 and K250307) and accompanying information to inform safe and effective use. The device modifications include material changes and there are no changes to Visualase Systems (V1 and V2 system)' hardware or software.

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Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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.

Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed eighteen models with the same IPL technology for hair removal, which is model CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017, DT017 Pro, DT025 Pro, DT025. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.

The device is only powered by the external power adapter and its IPL emission activation is by finger switch.

The Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.0cm2 (Model CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X) and 4.2cm2 (Model DT015 Pro, DT015, DT017, DT017 Pro, DT025, DT025 Pro) that is suitable for multiple hair removal areas, such as upper lip, chin, armpits, legs, arms, bikini area, chest, back, abdomen.

The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the Hair Removal Device has the Ice-cooling function (Model: CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12) and Sapphire Ice-cooling function (Model: CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017, DT017 Pro, DT025 Pro, DT025), which will be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.

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