AccessGUDID - DEVICE: Clear Rayz for Him Stormy (00851478007196)

GUDID

Device Identifier (DI) Information

Brand Name: Clear Rayz for Him Stormy
Version or Model: DPA-021-Stormy
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DPA-021-Stormy
Company Name: QUASAR BIO-TECH INC.

Primary DI Number: 00851478007196
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 849862912 *Terms of Use

Device Description: No matter what your age, skin type, or skin tone, the blue and red lights treat and heal acne anywhere on your body..

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?
62202	Blue/red/infrared phototherapy lamp	A portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.	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 [?]
K111286	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: 76fa81db-1a76-4820-a42f-ec565c686604
Public Version Date: July 07, 2020
Public Version Number: 4
DI Record Publish Date: September 19, 2016