FDA UDI In Commercial Distribution 🇺🇸 United States

Me

DI: 10806248006180 · Model: HU-FG00691WL · ILUMINAGE LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Me
Primary DI
10806248006180
Version / Model
HU-FG00691WL
Company Name
ILUMINAGE LTD
Labeler DUNS
533309022
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
3
Public Version Date
2020-02-24
Public Version Status
Update
Public Device Record Key
253f282d-8940-49ed-aa32-cf0f912e1285

Device Description

Over-the counter home use device that is intended for the removal of unwanted hair.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

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

GMDN Terms

Code Name
47704 Cosmetic red-light phototherapy system, home-use

Identifiers

Type ID
Package 20806248006187
Primary 10806248006180