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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 NIRA Precision Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a single USB C connector interface that provides battery charging. The NIRA Laser is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
117-000
In Commercial Distribution

  • 00850020752126 ()


  • Dermatological laser beam guiding handpiece
The NIRA PRO is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO consists of a hand piece, wall-plug battery charger, and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a USB C connector interface that provides battery charging. The NIRA PRO is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
151-000
In Commercial Distribution

  • 00850020752119 ()


  • Dermatological laser beam guiding handpiece
Handpiece Assembly
Candela Corporation
7122-00-3150
Not in Commercial Distribution

  • 08174950202219 ()


  • Dermatological laser beam guiding handpiece
Handpiece Assembly
Candela Corporation
7122-00-3080
Not in Commercial Distribution

  • 08174950202202 ()


  • Dermatological laser beam guiding handpiece
Handpiece Assembly
Candela Corporation
7122-00-3151
Not in Commercial Distribution

  • 08174950202226 ()


  • Dermatological laser beam guiding handpiece
Diode laser 808 nm
INTELLIGENCE TARGET SYSTEM SRL
G100.3000
In Commercial Distribution

  • 08056893740013 ()


  • Dermatological laser beam guiding handpiece
No Description
Tria Laser Inc
SRL
In Commercial Distribution

  • G7433426 ()
3426

  • Dermatological laser beam guiding handpiece
The Dual Yellow laser is indicated for the treatment of benign pigmented and cutaneous vascular lesions. The Dual Yellow laser, operating at 578 nm, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutaneous vascular lesions including but not limited to: Treatment of wrinkles, Periocular wrinkles, Periorbital wrinkles. Facial and leg telangiectasia, Rosacea, Cherry angiomas, Port wine stains, Hemangiomas and venous lakes, Angioma, Spider angioma, and Poikiloderma of Civatte, Inflammatory Acne Vulgaris, Verrucae/Warts, Scars, Striea, and Psoriasis. Podiatry - for benign cutaneous lesions and warts. The Dual Yellow lase, operating at 511 rn, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutaneous pigmented lesions including but not limited to: Lentigines, Solar keratoses, Adenoma serabaceum, Skin tabs, Trichoepitheliomas (benign lesions similar to skin tags) Naevi, Keratoses, Syringomas Seborrhoeic keratoses Verrucae vulgaris, and Warts.
NORSELD PTY. LIMITED
D10B Dual Yellow
In Commercial Distribution

  • B241D10B0 ()


  • Dermatological laser beam guiding handpiece
Twain 2940 for Quantaforte
QUANTA SYSTEM SPA
OAM001656
In Commercial Distribution

  • 08033945938406 ()


  • Dermatological laser beam guiding handpiece
No Description
QUANTA SYSTEM SPA
OAM002029
Not in Commercial Distribution

  • 08033945938321 ()


  • Dermatological laser beam guiding handpiece
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