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FDA 510(k)

B.Light Clear Evo and B.Light Restore Evo

K-Number: K223919 · 2023-09-23

ApplicantBemer Int AG
Decision Date2023-09-23
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

B.Light Clear Evo and B.Light Restore Evo is a medical device manufactured by Bemer Int AG. It received FDA 510(k) clearance on 2023-09-23 under approval number K223919. 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 B.Light Clear Evo and B.Light Restore Evo?

B.Light Clear Evo and B.Light Restore Evo is a medical device that received FDA 510(k) clearance on 2023-09-23. It is manufactured by Bemer Int AG. The 510(k) number is K223919.

When was B.Light Clear Evo and B.Light Restore Evo approved by the FDA?

B.Light Clear Evo and B.Light Restore Evo received FDA 510(k) clearance on 2023-09-23, under approval number K223919.

What company makes B.Light Clear Evo and B.Light Restore Evo?

B.Light Clear Evo and B.Light Restore Evo is manufactured by Bemer Int AG.

What is the FDA product code for B.Light Clear Evo and B.Light Restore Evo?

The FDA product code for B.Light Clear Evo and B.Light Restore Evo is OHS.

Related Clinical Trials

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Other Devices by Bemer Int AG

K151834BEMER Classic Set, BEMER Pro-Set K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set K231368Bemer Therapy System Evo

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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