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FDA 510(k)

Perfectio LED infrared device

K-Number: K152332 · 2016-02-25

ApplicantOmm Imports Inc Dba Zero Gravity
Decision Date2016-02-25
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Perfectio LED infrared device is the device name listed in this FDA 510(k) record. The listed applicant is Omm Imports Inc Dba Zero Gravity. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K152332. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Perfectio LED infrared device?

Perfectio LED infrared device is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Omm Imports Inc Dba Zero Gravity. The 510(k) number is K152332.

When did Perfectio LED infrared device receive FDA 510(k) clearance?

Perfectio LED infrared device received FDA 510(k) clearance on 2016-02-25, under 510(k) number K152332.

Who is the listed applicant for Perfectio LED infrared device?

The FDA 510(k) record lists Omm Imports Inc Dba Zero Gravity as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Perfectio LED infrared device?

The FDA product code for Perfectio LED infrared device is OHS.

Related Devices (Code: OHS)

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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