FDA UDI In Commercial Distribution 🇺🇸 United States

Iluminage

DI: 00806248007296 · Model: HU-FG01751 · Tanda Beauty Canada, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Iluminage
Primary DI
00806248007296
Version / Model
HU-FG01751
Company Name
Tanda Beauty Canada, Inc
Labeler DUNS
248047115
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-07-10
Public Version
3
Public Version Date
2020-02-24
Public Version Status
Update
Public Device Record Key
869c6075-645e-4cf4-bd7a-6a0a7d1f36ae

Device Description

Battery powered, home use (OTC) diode laser indicated for use in the treatment of periorbital and perioral wrinkles.

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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OHS Light Based Over The Counter Wrinkle Reduction

GMDN Terms

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

Identifiers

Type ID
Primary 00806248007296