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FDA 510(k)

DeepX DermoSight Dermatoscope

K-Number: K230448 · 2023-05-17

ApplicantDeepx Health, LLC
Decision Date2023-05-17
Product CodePSN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DeepX DermoSight Dermatoscope is a medical device manufactured by Deepx Health, LLC. It received FDA 510(k) clearance on 2023-05-17 under approval number K230448. The device is classified under product code PSN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DeepX DermoSight Dermatoscope?

DeepX DermoSight Dermatoscope is a medical device that received FDA 510(k) clearance on 2023-05-17. It is manufactured by Deepx Health, LLC. The 510(k) number is K230448.

When was DeepX DermoSight Dermatoscope approved by the FDA?

DeepX DermoSight Dermatoscope received FDA 510(k) clearance on 2023-05-17, under approval number K230448.

What company makes DeepX DermoSight Dermatoscope?

DeepX DermoSight Dermatoscope is manufactured by Deepx Health, LLC.

What is the FDA product code for DeepX DermoSight Dermatoscope?

The FDA product code for DeepX DermoSight Dermatoscope is PSN.

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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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