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Found 2008 results
510(k) Data Aggregation
(85 days)
The PICO-K is intended for use in the following indications at the specified wavelength:
1064 nm wavelength
- Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple
- Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV
- Treatment of acne scars in Fitzpatrick Skin Types II-V
- Treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I-IV
532 nm wavelength
- Tattoo removal in Skin Types I - III
- Treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV
The system consists of a power supply, laser resonator, touch LCD monitor, articulated arm, handpieces, foot switch, and laser protective eyewear. The system includes several safety features, including use of key switch, an interlock, emergency stop button, and need to press a footswitch in order to activate the laser. The main body transmits the laser energy through the articulating arm to the handpiece which is positioned above or in contact with the treatment area. Three different handpieces can be attached to the articulated arm, the Zoom handpiece, Collimated handpiece, and MLA handpiece. Each handpiece integrates and aiming beam that shows the treatment area.
The Nd:YAG laser surgical system employs a solid-state laser with a medium of Nd:YAG at 1064 nm and KTP at 532 nm. The energy from the 1064 nm wavelengths emitted by the laser is directed at the cells or tissues of the skin, raising the temperature of the targeted tissue according to the Selective Photothermolysis Theory. This selective heating of the tissue results in the cutting, destruction, or removal of the tissue through the heat energy produced by the laser.
PICO-K employs a patented resonator design with optics aligned under controlled thermal lensing conditions. At high repetition rates (8–10 Hz), thermal lensing of the Nd:YAG rod can degrade beam quality in conventional systems. In PICO-K, the lamp frequency is fixed at 8–10 Hz, optical alignment is optimized under these conditions, and laser emission is generated only at divisor frequencies (1, 2, 3, 4, 5, 8, 9, 10 Hz).
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(255 days)
The 1064 Laser Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
Dermatology:
Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented 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, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. Additionally, the lasers are indicated for 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.
When used with the specified treatment protocol, it is also intended for histological clearance of biopsy-confirmed nodular or superficial basal cell carcinoma (BCC) located on the trunk, in individuals with Fitzpatrick skin types I-II. The rate of recurrence after this procedure is not known.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The 1064 Laser System and Accessories are indicated for use on all skin types (Fitzpatrick I-Vl), including tanned skin.
The 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.
Surgical Applications:
Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.
The JOULE 1064nm Laser System is a device which delivers laser energy at a wavelength of 1064 nm. It consists of a console and laser delivery accessories. It uses focusing optics to deliver optical energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system with a treatment handpiece. The user activates laser emission by means of a footswitch.
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(262 days)
The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing.
CO2 Laser Therapy System (Model: LFS-D9U) uses infrared beam with a wavelength of 10.6 µm for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing. The device comprises a main unit, therapy head, light guide system, and footswitch.
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(100 days)
The SANDRO Dual Laser System is indicated for the following at the specified wavelength:
755nm
- Temporary hair reduction. Stable long-term or permanent reduction through selective 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 pant-wine stains, hemangiomas, telangiectasias)
1064nm
- Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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. 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 lake, leg veins 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, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
- The laser is indicated for 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.
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
- Treatment of wrinkles.
1064nm
- Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
The SANDRO Dual laser system consists of laser resonator, touch screen monitor, optical fiber with handpiece, and foot switch.
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Nd:YAG Laser
A certain amount of electric power set by the LCD monitor is permitted to the laser resonator through the power supply. Then, the laser resonator delivers the electrical energy to the flash lamp which converts the electrical energy into the light source. This concentrated light source is radiated on the medium of Nd:YAG, resulting in the laser energy source. The laser energy generated by the medium of Nd:YAG is converted to the heat energy once it gets to human skin surface and used for a variety of medical purpose such as an ablation, incision and removal of targeted tissue. -
Alexandrite Laser
A certain amount of electric power set by the LCD monitor is permitted to the laser resonator through the power supply. Then, the laser resonator delivers the electrical energy to the flash lamp which converts the electrical energy into the light source. This concentrated light source is radiated on the medium of Alexandrite, resulting in the ultimate laser energy source. The laser energy generated by the medium of Alexandrite is converted to the heat energy once it gets to human skin surface and used for a variety of medical purpose such as an ablation, incision and removal of targeted tissue.
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(105 days)
Halo Sterile Single-use Radial Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm - 2200nm have received regulatory clearance. Halo Sterile Single-use Radial Fibers are intended for use with any cleared surgical laser with an SMA 905 connector.
The Halo Sterile Single - use Radial Fibers (Model: Halo - R - 0.40 - 2.5/Halo - R - 0.60 - 2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8), as surgical laser fibers, are suitable for use in combination with commercially available diode laser systems with a wavelength ranging from500nm to 2200nm and equipped with SMA905 connectors. The output power should not exceed 30 W. This device is single use only and sterilized by EO gas.The Halo Sterile Single - use Radial Fibers are intended for general surgical operations such as incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissues in either contact or non - contact mode. In particular, they are designed for endovascular coagulation of blood vessels.The Fiber is radial-typed fiber. The shape of distal end of fiber is conical to radiate laser radially.
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(98 days)
The Medical Diode Laser Systems are intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for: Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux.
The Medical Diode Laser Systems generate a 980nm wavelength laser to act on a target tissue to achieve resection, hemostasis, ablation, and coagulation of the target tissue.
The Medical Diode Laser Systems generate a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
The Medical Laser Family has following characteristics:
- Dual wavelengths
- Temperature monitoring system
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(56 days)
BELLUS-Q, Q switched Nd:YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
1064 nm wavelength in Q-switched mode:
- Removal of dark (black, blue, brown) tattoo ink
- Treatment of nevus of ota
- Treatment of common nevi
- Removal and lightening of unwanted hair
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Treatment of melasma
- General dermatology indications: Incision, excision, ablation and vaporization of soft tissue
1064 nm wavelength in GENESIS mode:
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris
532 nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces):
- Red, tan, purple and orange tattoo ink removal
- Sky blue (light) tattoo ink removal
- Green tattoo ink removal
- Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus
- Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
- Seborrheic Keratosis
- Treatment of post-inflammatory hyperpigmentation
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Removal of epidermal pigmented lesions
The system consists of a power supply, laser resonator, touch LCD monitor, articulated arm, handpieces, foot switch, and laser protective eyewear. The system includes several safety features, including use of key switch, an interlock, emergency stop button, and need to press a footswitch in order to activate the laser. The main body transmits the laser energy through the articulating arm to the handpiece which is positioned above or in contact with the treatment area. Five different handpieces can be attached to the articulated arm, the Zoom handpiece, Collimated handpiece, MLA handpiece, 585 Dye handpiece, and the 650 Dye handpiece. In addition, the system can operate in different modes, including single pulse, PTP, 3-pulse, 6-pulse, and genesis modes. Each handpiece integrates and aiming beam that shows the treatment area.
The Nd:YAG laser surgical system utilizes a solid-state laser medium of Nd:YAG at 1064 nm and KTP at 532 nm. The 1064 nm and 532 nm wavelengths interact with targeted skin cells or tissues, primarily leveraging the Photothermolysis Effect in Q-switched nanosecond pulse modes. This selective photothermolysis mechanism enables controlled thermal absorption within target chromophores, leading to coagulation, denaturation, or vaporization of melanin-containing cells while preserving surrounding tissues. The laser energy is effectively absorbed by pigmented lesions, allowing for precise and efficient treatment in dermatological applications.
The system also supports Dye handpieces, which enable the use of 585 nm and 650 nm wavelengths by converting 532 nm light. These wavelengths have greater absorption for different specific pigment-related lesions, expanding the system's versatility in medical and aesthetic procedures.
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(57 days)
The LeafPure-Echo is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:
1064nm wavelength:
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colours: black, brown, green, blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colours: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
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(83 days)
The Holmium laser system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynecology, ENT and General Surgery.
The Potent HP Series is a family of pulsed solid-state Holmium:YAG laser systems that deliver energy at a wavelength of 2100 nm through optical fibers for soft tissue surgery and stone fragmentation. The system utilizes a flashlamp-pumped Ho:YAG laser medium, and the laser energy is transmitted to the target site via SMA905-compatible optical fibers. All models in the series share the same fundamental design and operational principles, differing in maximum average power output and frequency. The system includes a touchscreen interface, dual-pedal footswitch, fiber auto-recognition, integrated liquid cooling, and multiple built-in safety features such as an emergency stop, door interlock, and real-time monitoring of laser output.
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(83 days)
The Thulium Fiber Laser System is intended for incision, excision, resection, ablation, coagulation, hemostasis and vaporization of soft tissue, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
Urology
- Ablation of Benign Prostatic Hyperplasia (BPH)
- Laser Resection of the Prostate (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
- Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate monohydrate and calcium oxalate dehydrate stones
- Endoscopic fragmentation of renal calculi
- Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed
Gastroenterology
open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:
- Appendectomy
- Angiodysplasia
- Polyps
- Colorectal cancer
- Biopsy
- Telangiectasias
- Gall Bladder calculi
- Telangiectasias of the osler-weber-Renu disease
- Biliary/Bile duct calculi vascular Malformation
- Ulcers
- Gastritis
- Gastric ulcers
- Esophagitis
- Duodenal ulcers
- Esophageal ulcers
- Non Bleeding ulcers
- Varices
- Pancreatitis
- Colitis
- Haemorrhoids
- Mallory-weiss tear
- Cholecystectomy
- Gastric Erosions
- Benign and Malignant Neoplasm
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue
The Thulium Fiber Laser System is a pulsed solid-state Thulium fiber laser system that delivers energy at a wavelength of 1940 nm through optical fibers for soft tissue surgery and stone fragmentation. The system utilizes a diode-pumped Thulium-doped fiber laser medium, and the laser energy is transmitted to the target site via standard optical fibers. The system is designed for surgical applications requiring precise tissue ablation, coagulation, and stone fragmentation.
The system includes an intuitive touchscreen interface, dual-pedal foot switch, integrated cooling system, and comprehensive safety features including emergency stop, door interlock, key switch, and real-time monitoring of laser parameters.
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