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FDA 510(k)

VARAYA AR , VARAYA SPORT

K-Number: K112494 · 2012-05-16

ApplicantVaraya Photoceuticals, LLC
Decision Date2012-05-16
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

VARAYA AR , VARAYA SPORT is the device name listed in this FDA 510(k) record. The listed applicant is Varaya Photoceuticals, LLC. It received FDA 510(k) clearance on 2012-05-16 under 510(k) number K112494. 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 VARAYA AR , VARAYA SPORT?

VARAYA AR , VARAYA SPORT is a medical device that received FDA 510(k) clearance on 2012-05-16. The listed applicant is Varaya Photoceuticals, LLC. The 510(k) number is K112494.

When did VARAYA AR , VARAYA SPORT receive FDA 510(k) clearance?

VARAYA AR , VARAYA SPORT received FDA 510(k) clearance on 2012-05-16, under 510(k) number K112494.

Who is the listed applicant for VARAYA AR , VARAYA SPORT?

The FDA 510(k) record lists Varaya Photoceuticals, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARAYA AR , VARAYA SPORT?

The FDA product code for VARAYA AR , VARAYA SPORT 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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