AccessGUDID - DEVICE: ESPADA Acne-Clearing Blue Light Pen (07350092130288)

GUDID

Device Identifier (DI) Information

Brand Name: ESPADA Acne-Clearing Blue Light Pen
Version or Model: ESPADA Magenta
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Foreo AB

Primary DI Number: 07350092130288
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 352394143 *Terms of Use

Device Description: The ESPADA Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatment of mild to moderate inflammatory acne.

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLP	Over-The-Counter Powered Light Based Laser For Acne

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162450	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: 16d99ce5-1e5d-4a1b-9072-32b523d80dbf
Public Version Date: December 05, 2022
Public Version Number: 3
DI Record Publish Date: January 09, 2017