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FDA 510(k)

LUMIWAVE 1X4 INFRARED THERAPY DEVICE

K-Number: K051816 · 2005-08-26

ApplicantBiocare Systems, Inc.
Decision Date2005-08-26
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LUMIWAVE 1X4 INFRARED THERAPY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Biocare Systems, Inc.. It received FDA 510(k) clearance on 2005-08-26 under 510(k) number K051816. 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 LUMIWAVE 1X4 INFRARED THERAPY DEVICE?

LUMIWAVE 1X4 INFRARED THERAPY DEVICE is a medical device that received FDA 510(k) clearance on 2005-08-26. The listed applicant is Biocare Systems, Inc.. The 510(k) number is K051816.

When did LUMIWAVE 1X4 INFRARED THERAPY DEVICE receive FDA 510(k) clearance?

LUMIWAVE 1X4 INFRARED THERAPY DEVICE received FDA 510(k) clearance on 2005-08-26, under 510(k) number K051816.

Who is the listed applicant for LUMIWAVE 1X4 INFRARED THERAPY DEVICE?

The FDA 510(k) record lists Biocare Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUMIWAVE 1X4 INFRARED THERAPY DEVICE?

The FDA product code for LUMIWAVE 1X4 INFRARED THERAPY DEVICE is ILY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Biocare Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K042532BIOCARE SYSTEMS PREMIR 818

Related Devices (Code: ILY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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