AccessGUDID - DEVICE: SensiLight - salmon (05060445340029)

GUDID

Device Identifier (DI) Information

Brand Name: SensiLight - salmon
Version or Model: IPL050US02SNS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EL GLOBAL TRADE LTD

Primary DI Number: 05060445340029
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649726981 *Terms of Use

Device Description: The sensiLight is an over the counter device intended for the removal of unwanted hair. The sensiLight is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.

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):	No
Over the Counter (OTC):	Yes
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?
58935	Intense pulsed light skin surface treatment system	A mains electricity (AC-powered) mobile (on wheels) device designed to produce strong, controlled flashes of filtered light in the wavelength range 400 - 1200nm [intense pulsed light (IPL)] for heat ablation of pigmented skin cells (selective photothermolysis) to treat multiple skin/pigmentation conditions. The device typically enables variation of treatment parameters (wavelength, duration of impulses, single/multiple impulses) for treatment of conditions such as acne, telangiectasia, pigmentation (freckles, sun spots, liver spots) and/or for hair reduction. It consists of a control unit with user interface display and control panel, and a wire-connected applicator.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHT	Light Based Over-The-Counter Hair Removal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140381	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: 0f826224-9c7b-45ff-8f3c-c12cfa7bcc12
Public Version Date: October 19, 2021
Public Version Number: 5
DI Record Publish Date: October 19, 2016