FDA 510(k)

Opera Lebody (Gold), Opera Lebody (Zafiro)

K-Number: K201107 · 2020-06-22

Decision Date2020-06-22

Product CodeOHS

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Opera Lebody (Gold), Opera Lebody (Zafiro) is a medical device manufactured by Gtg Wellness Co., Ltd.. It received FDA 510(k) clearance on 2020-06-22 under approval number K201107. 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 Opera Lebody (Gold), Opera Lebody (Zafiro)?

Opera Lebody (Gold), Opera Lebody (Zafiro) is a medical device that received FDA 510(k) clearance on 2020-06-22. It is manufactured by Gtg Wellness Co., Ltd.. The 510(k) number is K201107.

When was Opera Lebody (Gold), Opera Lebody (Zafiro) approved by the FDA?

Opera Lebody (Gold), Opera Lebody (Zafiro) received FDA 510(k) clearance on 2020-06-22, under approval number K201107.

What company makes Opera Lebody (Gold), Opera Lebody (Zafiro)?

Opera Lebody (Gold), Opera Lebody (Zafiro) is manufactured by Gtg Wellness Co., Ltd..

What is the FDA product code for Opera Lebody (Gold), Opera Lebody (Zafiro)?

The FDA product code for Opera Lebody (Gold), Opera Lebody (Zafiro) is OHS.

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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.