FDA UDI
In Commercial Distribution
🇺🇸 United States
Poly Go
DI: B3437000C1
·
Model: 7000C
·
Medtek Lighting Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Poly Go
- Primary DI
- B3437000C1
- Version / Model
- 7000C
- Company Name
- Medtek Lighting Corporation
- Labeler DUNS
- 002692106
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-01
- Public Version
- 3
- Public Version Date
- 2020-07-07
- Public Version Status
- Update
- Public Device Record Key
- ccb3242b-c72d-4d9a-87ad-756e706c5897
Device Description
Handheld LED Light Therapy Device. Treatment heads, available in Red (633nm), Blue (415nm) and Infrared (850nm), help to mitigate a variety of skin conditions. There are 48 LEDs to provide a treatment area of 26 square cm. Battery powered with a charger.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PWC | General Wellness Product | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B3437000C1 | HIBCC |