ACP Omnipad Light Therapy System & ACP Omnipad 500 Control Unit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K060191 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 ACP Omnipad Light Therapy System & ACP Omnipad 500 Control Unit is a light therapy device used in physical medicine applications. It is designed to deliver therapeutic light energy for clinical treatment purposes.
The system is supplied as a reusable device and is intended for use in clinical settings. It received FDA 510(k) clearance under K060191 with product code ILY and was determined to be substantially equivalent to a predicate device. The device is manufactured by Accelerated Care Plus Corp. and is authorized for marketing in the United States.
Frequently asked questions
What is the ACP Omnipad Light Therapy System used for?
The ACP Omnipad Light Therapy System is designed to deliver therapeutic light energy for clinical treatment in physical medicine applications, as indicated in its FDA 510(k) submission for light therapy in clinical settings.
Is the ACP Omnipad Light Therapy System reusable or single-use?
The system is supplied as a reusable device intended for repeated use in clinical settings, as stated in the device description which specifies it is designed for reuse in physical medicine applications.
What regulatory pathway was used for the ACP Omnipad Light Therapy System?
The device received FDA 510(k) clearance under submission K060191, demonstrating substantial equivalence to a predicate device with product code ILY, and was cleared via the traditional 510(k) pathway.
Who manufactures the ACP Omnipad Light Therapy System & Control Unit?
The ACP Omnipad Light Therapy System and ACP Omnipad 500 Control Unit are manufactured by Accelerated Care Plus Corp., located at 9855 Double R Blvd. #100, Reno, NV 89521, as listed in the device authorization details.
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: Microsoft campus - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060191 | Class II | Active |
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Manufacturer
- Manufacturer
- Accelerated Care Plus Corp.
Sources (1)
- FDA 510(k) K060191 24 fields · synced Sep 23, 2026