AccessGUDID - DEVICE: LED MASK PLATINUM MD (08809362081458)

GUDID

Device Identifier (DI) Information

Brand Name: LED MASK PLATINUM MD
Version or Model: MQ-M21M4
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STG24 Co.,Ltd.

Primary DI Number: 08809362081458
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688323797 *Terms of Use

Device Description: This product irradiates the skin with red light in the wavelength range of 630 to 690 nm and infrared light in the wavelength range of 820 to 880 nm. Treatment of wrinkles all over the face. This product is designed as a portable personal medical device with a built-in battery, not a wired power supply. It is a mask-type product that is worn on the face. The operating mode of the product can be easily changed by hand. After connecting the charging adapter to the cradle, attach the main unit to the cradle to wirelessly charge the main unit with only the cradle. In addition, eye shield (for eye protection, opening/closing covers, vacuum cleaner towels, power cables, etc. are provided for convenient service use.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47704	Cosmetic red-light phototherapy system, home-use	An assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHS	Light Based Over The Counter Wrinkle Reduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K222377	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -20 and 50 Degrees Celsius
Handling Environment Humidity: between 20 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2ce1dbb5-0c89-453f-9222-3dc58d8d9259
Public Version Date: May 16, 2023
Public Version Number: 2
DI Record Publish Date: February 23, 2023