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FDA 510(k)

PHAROS

K-Number: K250170 · 2025-08-15

ApplicantBrightonix Imaging
Decision Date2025-08-15
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHAROS is a medical device manufactured by Brightonix Imaging. It received FDA 510(k) clearance on 2025-08-15 under approval number K250170. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHAROS?

PHAROS is a medical device that received FDA 510(k) clearance on 2025-08-15. It is manufactured by Brightonix Imaging. The 510(k) number is K250170.

When was PHAROS approved by the FDA?

PHAROS received FDA 510(k) clearance on 2025-08-15, under approval number K250170.

What company makes PHAROS?

PHAROS is manufactured by Brightonix Imaging.

What is the FDA product code for PHAROS?

The FDA product code for PHAROS is KPS.

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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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