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FDA 510(k)

OR-LIGHT

K-Number: K090724 · 2009-10-07

ApplicantYperion Technology
Decision Date2009-10-07
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OR-LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Yperion Technology. It received FDA 510(k) clearance on 2009-10-07 under 510(k) number K090724. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OR-LIGHT?

OR-LIGHT is a medical device that received FDA 510(k) clearance on 2009-10-07. The listed applicant is Yperion Technology. The 510(k) number is K090724.

When did OR-LIGHT receive FDA 510(k) clearance?

OR-LIGHT received FDA 510(k) clearance on 2009-10-07, under 510(k) number K090724.

Who is the listed applicant for OR-LIGHT?

The FDA 510(k) record lists Yperion Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OR-LIGHT?

The FDA product code for OR-LIGHT is ONF.

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Related Devices (Code: ONF)

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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