Copper Bromide Laser - The Dual Yellow laser is indicated for the - NORSELD PTY. LIMITED

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORSELD PTY. LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1