FDA UDI In Commercial Distribution 🇺🇸 United States

Ulike

DI: 06974667828236 · Model: UI06 LY · Shenzhen Ulike Smart Electronics Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Ulike
Primary DI
06974667828236
Version / Model
UI06 LY
Company Name
Shenzhen Ulike Smart Electronics Co., Ltd.
Labeler DUNS
618646978
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-12-10
Public Version
1
Public Version Date
2025-12-18
Public Version Status
New
Public Device Record Key
8fe41578-6da0-45cd-8d57-67cfc39d11f5

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
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

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

GMDN Terms

Code Name
65776 Home-use intense pulsed light hair removal unit

Identifiers

Type ID
Package 16974667828233
Primary 06974667828236

Premarket Submissions

Submission Number Supplement Number
K252804 000