CLEANE

Primary DI: 08809216198103
Brand: CLEANE
Company: MEDICON CO., LTD
Model: CLEANE
Published: 2020-08-15
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
OTC: true

Product Codes#

Code, Name table
Code	Name
OZC	Over The Counter Thermal Treatment For Acne.

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
OZC	Over The Counter Thermal Treatment For Acne.	Physical Medicine	2

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
K111341	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K111341	000	CLEANE / CLEANE POP	Medicon Co., Ltd.	2012-02-29	OZC

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
08809216198103	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifier	GTIN-14 normalized	EAN-13
08809216198103	08809216198103	8809216198103

GMDN Terms#

Term, Definition table
Term	Definition
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number: 688209532
Device count: 1
Serial number: true