Identity
- Trade Name
- Poly Spot FDA UDI
- Generic Name
- Blue/red/infrared phototherapy lamp FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- 7000C2 FDA UDI
- 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B3437000C21 FDA UDI
- FDA Product Code
- PWC FDA UDI
- GMDN Term
- Blue/red/infrared phototherapy lamp FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Area/Surface Area — 4 Square centimeter FDA UDI
Category: Blue/red/infrared phototherapy lamp
Poly Spot by Medtek Lighting Corp — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blue/red/infrared phototherapy lamp.
- Dermalux — Aesthetic Technology, Ltd. · Class II
- Celluma — BioPhotas, Inc. · Class II
- reVive Light Therapy® — LED TECHNOLOGIES, INC. · Class II
- Dr Dennis Gross Skincare — LED TECHNOLOGIES, INC. · Class II
- LESCOLTON — Shenzhen Lescolton Medical Equipment Co., Ltd. · Class II
- Platinum LED Therapy Lights — PLATINUM LED HOLDINGS LLC · Class II
- LESCOLTON — Shenzhen Lescolton Medical Equipment Co., Ltd. · Class II
- Platinum LED Therapy Lights — PLATINUM LED HOLDINGS LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class N | Pending data |
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Manufacturer
- Manufacturer
- Medtek Lighting Corp
Sources (1)
- FDA UDI ea76ccd1-bcf6-48de-9214-92d6c7d16caa 34 fields · synced May 30, 2026