Intense Pulsed Light (IPL) System

Basic Information

• Brand Name: Intense Pulsed Light (IPL) System
• Primary DI: 06971008271102
• Version / Model: T023B
• Company Name: Shenzhen Fansizhe Science And Technology Co., Ltd.
• Labeler DUNS: 417663470
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-14
• Public Version: 1
• Public Version Date: 2023-04-24
• Public Version Status: New
• Public Device Record Key: 23e9de99-9420-46a2-ae66-d1e582332235

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: 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: 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	06971008271102	GS1

Premarket Submissions

Submission Number	Supplement Number
K223928	000