Identifiers
- 510(k) Number
- K081570 FDA 510(k)
- FDA Product Code
- ILY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5500 FDA 510(k)
- Regulation Number
- 890.5500 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DPL Therapy System is a compact infrared lamp for therapeutic heating. It delivers infrared light to the skin resulting in a safe elevation of the skin temperature for therapeutic effects.
The device is supplied as a reusable system and is intended for use in clinical or home settings. It has received FDA 510(k) clearance under K081570 and is classified under product code ILY with advisory committee review in Physical Medicine.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Medical Grade LED Light Skin Therapy | LED Technologies, Inc, Shop All reVive Light Therapy™ and dpl® Products - LED Technologies, Inc, LED Technologies, LLC Therapy System Panels User Guide, LED TECHNOLOGIES DPL THERAPY USER MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081570 | Class II | Active |
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Manufacturer
- Manufacturer
- Led Technologies, LLC
Sources (1)
- FDA 510(k) K081570 24 fields · synced Sep 22, 2026