AccessGUDID - DEVICE: L-650 (07290016681390)

GUDID

Device Identifier (DI) Information

Brand Name: L-650
Version or Model: FS90015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FS90015
Company Name: FORMATK SYSTEMS LTD

Primary DI Number: 07290016681390
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532396673 *Terms of Use

Device Description: IPL (Intense Pulsed Light ) Applicator to be used with Formatk Systems Ltd supporting systems for the treatment of Pigmented lesions and removal of unwanted hair

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 [?]
K183307	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: 4d986144-971b-4623-b7ba-452e61ab1cab
Public Version Date: January 16, 2019
Public Version Number: 1
DI Record Publish Date: December 16, 2018