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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The MOTUS PRO is a medical laser equipped with Alexandrite 755nm laser and Nd:YAG 1064nm laser. The laser sources deliver the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition.
DEKA M.E.L.A. SRL
M130N1
In Commercial Distribution

  • 08034108512891 ()


  • Multi-modality skin surface treatment system
The SMARTXIDE TETRA PRO DEVICE consists of a 10,600nm carbon dioxide laser (CO2) laser with 40W of maximum power. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end. The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis regardless of the arm orientation. The device may be used in combination with scanning units in order to achieve greater predictability and reproducibility. The use with the scanning units is indicated for layer-by-layer char-free ablation, enhancing the safety of the treatment with more uniform, accurate and controllable impact such as ablative skin resurfacing.
DEKA M.E.L.A. SRL
M118G1
In Commercial Distribution

  • 08034108512808 ()


  • General/multiple surgical carbon dioxide laser system
The SmartXide PRO is a medical device indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues incluing intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
DEKA M.E.L.A. SRL
M079BI1
In Commercial Distribution

  • 08034108512709 ()
M079R1

  • Dermatological carbon dioxide laser system
The Elite iQ PRO Laser System is indicated fot stable long-term or permanent hair reduction. Peramanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 or 12 months after the completiomn of a treatment regime. It is used for skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. 1064nm: The Elite iQ PRO 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, venous lakes, leg veins, spider wine and poikiloderma of Civatte; and treatment of benign cutaneous lesions such as, but not limited to, lentigines (age spots), solar lentigines (sunspots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the treatment of psuedo folliculitis barbae (PFB) and for stable long-term or permanent hair reduction. 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 the competition of a treatment regime. The Skintel Reader is intended as an onbjective measurement tool for examing skin melanin content for determing and setting a test spot starting fluence.
DEKA M.E.L.A. SRL
M122K1
In Commercial Distribution

  • 08034108512655 ()
M122K1

  • Multi-modality skin surface treatment system
The DEKA AGAIN PRO family is a medical laser family equipped with Alexandrite 755nm laser and Nd:YAG 1064nm laser. The laser sources deliver the laser output through a lens coupled user repleaceable optical fiber with a wider range of intercheangeable, quick release laser handpieces with electronic spot recognition.
DEKA M.E.L.A. SRL
M126AA1
In Commercial Distribution

  • 08034108512525 ()


  • Multi-modality skin surface treatment system
I-MAX 3D CEPH version
OWANDY RADIOLOGY
I-MAX 3D PAN CEPH 110-120V
In Commercial Distribution

  • 03760262651828 ()
9304301011

  • Stationary panoramic/tomographic dental x-ray system, digital
I-MAX 3D PAN version 100-120V with floor-mounted column
OWANDY RADIOLOGY
I-MAX 3D PAN ONLY FLOOR 100-120V
In Commercial Distribution

  • 03760262651804 ()
9304100011.FL

  • Stationary panoramic/tomographic dental x-ray system, digital
I-MAX CEPH version with double sensor
OWANDY RADIOLOGY
I-MAX PAN CEPH DOUBLE SENSOR 110-120V
In Commercial Distribution

  • 03760262651637 ()
9304201011.DS

  • Stationary panoramic/tomographic dental x-ray system, digital
I-MAX CEPH version
OWANDY RADIOLOGY
I-MAX PAN CEPH 110-120V
In Commercial Distribution

  • 03760262651620 ()
9304201011

  • Stationary panoramic/tomographic dental x-ray system, digital
I-MAX PAN version 100-120V with floor-mounted column
OWANDY RADIOLOGY
I-MAX PAN ONLY FLOOR 100-120V
In Commercial Distribution

  • 03760262651606 ()
9304000011.FL

  • Stationary panoramic/tomographic dental x-ray system, digital
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