CLEANE

Basic Information

• Brand Name: CLEANE
• Primary DI: 08809216198103
• Version / Model: CLEANE
• Company Name: MEDICON CO., LTD
• Labeler DUNS: 688209532
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-15
• Public Version: 1
• Public Version Date: 2020-08-24
• Public Version Status: New
• Public Device Record Key: e46aaa54-add1-4fba-bb95-61cde56d28ba

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	Medical Specialty	Regulation #	Device Class
OZC	Over The Counter Thermal Treatment For Acne.	Physical Medicine	890.5740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62414	Blue-light phototherapy lamp, home-use	A hand-held, battery-powered device designed to emit blue light (e.g., 400-450nm) for phototherapy applications to treat skin diseases such as acne, rosacea, and psoriasis by the patient in the home. This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809216198103	GS1

Premarket Submissions

Submission Number	Supplement Number
K111341	000