AccessGUDID - DEVICE: Me (00806248006114)

GUDID

Device Identifier (DI) Information

Brand Name: Me
Version or Model: Series 14
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HU-FG01271
Company Name: Tanda Beauty Canada, Inc

Primary DI Number: 00806248006114
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 248047115 *Terms of Use

Device Description: Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the treatment of mild to moderate inflammatory acne.

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?
62116	Red/blue light phototherapy unit	A portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLP	Over-The-Counter Powered Light Based Laser For Acne

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 0489eb83-4174-4f7b-b84b-631022ec31df
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016