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FDA 510(k)

EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X

K-Number: K083560 · 2008-12-11

ApplicantLighthouse Technical Innovations, Inc.
Decision Date2008-12-11
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X is the device name listed in this FDA 510(k) record. The listed applicant is Lighthouse Technical Innovations, Inc.. It received FDA 510(k) clearance on 2008-12-11 under 510(k) number K083560. 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 EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X?

EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X is a medical device that received FDA 510(k) clearance on 2008-12-11. The listed applicant is Lighthouse Technical Innovations, Inc.. The 510(k) number is K083560.

When did EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X receive FDA 510(k) clearance?

EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X received FDA 510(k) clearance on 2008-12-11, under 510(k) number K083560.

Who is the listed applicant for EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X?

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

What is the FDA product code for EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X?

The FDA product code for EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X 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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