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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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Tria Laser Inc
FANp
In Commercial Distribution

  • B5863503 ()
3503

  • Dermatological laser beam guiding handpiece
Smooth Beauty Laser - Lilac
Tria Laser Inc
SRL
In Commercial Distribution

  • B5863426 ()
3426

  • Dermatological laser beam guiding handpiece
Skin Renu Laser
Tria Laser Inc
SRL
In Commercial Distribution

  • B58613752 ()
13752

  • 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
External Handpiece Sterile Single-Use, Blister Packaged, CO2RE Intima
Candela Corporation
AS95201
In Commercial Distribution

  • 00817495025063 ()


  • Dermatological laser beam guiding handpiece
Regular Internal Handpiece Sterile Single-Use, Blister Packaged, CO2RE Intima
Candela Corporation
AS95191
In Commercial Distribution

  • 00817495025056 ()


  • Dermatological laser beam guiding handpiece
External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
Candela Corporation
KT77911
In Commercial Distribution

KT77911

  • Dermatological laser beam guiding handpiece
Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
Candela Corporation
KT77821
In Commercial Distribution

KT77821

  • Dermatological laser beam guiding handpiece
Intima Sterile 2 Internal + 1 External HP, Accessories Kit
Candela Corporation
KT78011
In Commercial Distribution

KT78011

  • Dermatological laser beam guiding handpiece
Hand Piece Internal hygienic, Packaged, CO2RE Intima
Candela Corporation
AS89734
In Commercial Distribution

  • 00817495024417 ()


  • Dermatological laser beam guiding handpiece
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