AccessGUDID - DEVICE: SR580 applicator (07290016540406)

GUDID

Device Identifier (DI) Information

Brand Name: SR580 applicator
Version or Model: AS120032
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VENUS CONCEPT LTD

Primary DI Number: 07290016540406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533127663 *Terms of Use

Device Description: IPL applicator. Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules. Treatment of benign cutaneous vascular lesions including: port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of civatte, leg veins and venous malformations

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?
45222	Light-energy skin surface treatment system applicator	A handpiece that is part of a skin surface treatment system that conducts one or more generated light energies [e.g., fluorescent, ultraviolet B (UVB)] used for ablative and non-ablative treatment of skin conditions (e.g., acne, psoriasis, vascular lesions, wrinkles, large pores). This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153717	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: 5762d719-1be3-4711-8773-4a01f260ffd5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016