AccessGUDID - DEVICE: Copper Bromide Laser (B241D10B0)

GUDID

Device Identifier (DI) Information

Brand Name: Copper Bromide Laser
Version or Model: D10B Dual Yellow
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NORSELD PTY. LIMITED

Primary DI Number: B241D10B0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 756169231 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45221	Dermatological laser beam guiding handpiece	A hand-held component of a dermatological laser system designed to conduct a therapeutic laser (e.g., solid state laser) from the laser generator to the treatment site for ablative and non-ablative treatment of the skin (e.g., removal of pigment/vascular lesions, scarring, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032397	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

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