AccessGUDID - DEVICE: Poly Spot (B3437000C21)

GUDID

Device Identifier (DI) Information

Brand Name: Poly Spot
Version or Model: 7000C2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medtek Lighting Corporation

Primary DI Number: B3437000C21
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002692106 *Terms of Use

Device Description: Handheld LED Light Therapy Device. Treatment heads, available in Blue (415nm) or Red (633nm), help to mitigate a variety of skin conditions. There are 8 LEDs to provide a treatment area of 4 sq. cm. Batery powered with a charger

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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
PWC	General Wellness Product

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Area/Surface Area: 4 Square centimeter

Device Record Status

Public Device Record Key: ea76ccd1-bcf6-48de-9214-92d6c7d16caa
Public Version Date: July 07, 2020
Public Version Number: 3
DI Record Publish Date: September 01, 2017