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FDA 510(k)

ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT

K-Number: K060191 · 2006-07-12

ApplicantAccelerated Care Plus Corp.
Decision Date2006-07-12
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Accelerated Care Plus Corp.. It received FDA 510(k) clearance on 2006-07-12 under 510(k) number K060191. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT?

ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT is a medical device that received FDA 510(k) clearance on 2006-07-12. The listed applicant is Accelerated Care Plus Corp.. The 510(k) number is K060191.

When did ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT receive FDA 510(k) clearance?

ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT received FDA 510(k) clearance on 2006-07-12, under 510(k) number K060191.

Who is the listed applicant for ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT?

The FDA 510(k) record lists Accelerated Care Plus Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT?

The FDA product code for ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT is ILY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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