AccessGUDID - DEVICE: SMOOTHSKIN DuoLux Mini Collagen+ LED Eye Patches (05060534510951)

GUDID

Device Identifier (DI) Information

Brand Name: SMOOTHSKIN DuoLux Mini Collagen+ LED Eye Patches
Version or Model: TN2189
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: I-SMART DEVELOPMENTS LIMITED

Primary DI Number: 05060534510951
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 223616320 *Terms of Use

Device Description: SMOOTHSKIN DuoLux Mini Collagen+ LED Eye Patches Mini LED Patches to treat facial wrinkles Rebrand of Luma Eye Patch (TN2189)

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 [?]
K231555	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6c896ec6-9431-42d8-87e1-1c66777fc90a
Public Version Date: August 30, 2024
Public Version Number: 1
DI Record Publish Date: August 22, 2024