Duns Number:756169231
Device Description: The Dual Yellow laser is indicated for the treatment of benign pigmented and cutaneous vas 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.
Catalog Number
-
Brand Name
Copper Bromide Laser
Version/Model Number
D10B Dual Yellow
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K032397
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
23848235-75f8-4418-a154-2544469486ba
Public Version Date
May 24, 2021
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |