FDA UDI
In Commercial Distribution
🇺🇸 United States
POLY
DI: B3437000A1
·
Model: 7000A
·
Medtek Lighting Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- POLY
- Primary DI
- B3437000A1
- Version / Model
- 7000A
- Company Name
- Medtek Lighting Corporation
- Labeler DUNS
- 002692106
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-31
- Public Version
- 6
- Public Version Date
- 2020-07-07
- Public Version Status
- Update
- Public Device Record Key
- 7719b4d5-eb9d-4f81-99ec-03b2f859e073
Device Description
LED Light Therapy Device. Uses 1820 LEDs. LEDs may be Red (633nm), Blue (415nm) and/or Infrared (850nm). The wavelengths are available individually on treatment heads or a mix of wavelengths on the same treatment head. There is a Touch Screen Display for entering treatment times and selecting treatment heads. The unit is mounted on a base with casters for moving around a clinic.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
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 | B3437000A1 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170187 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Area/Surface Area | 800 | Square centimeter | |
| Weight | 60 | Pound |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 55 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 500 – 1060 millibar