Ulike

Basic Information

• Brand Name: Ulike
• Primary DI: 06974667826010
• Version / Model: UI06 PR
• 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: 2023-03-06
• Public Version: 1
• Public Version Date: 2023-03-14
• Public Version Status: New
• Public Device Record Key: 97b747e8-9dfb-4f88-bf85-d4296fcddde0

Device Description

IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OHT	Light Based Over-The-Counter Hair Removal	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65776	Home-use intense pulsed light hair removal unit	A hand-held, electrically-powered device designed to be used in the home to produce strong, controlled flashes of filtered light in the wavelength range of 400 - 1200nm [intense pulsed light (IPL)] for self-removal of unwanted hair.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974667826010	GS1
Package	16974667826017	GS1		8	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K223618	000