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FDA 510(k)

Resolve Fundus Camera

K-Number: K250683 · 2025-04-30

ApplicantOptain Health, Inc.
Decision Date2025-04-30
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Resolve Fundus Camera is a medical device manufactured by Optain Health, Inc.. It received FDA 510(k) clearance on 2025-04-30 under approval number K250683. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Resolve Fundus Camera?

Resolve Fundus Camera is a medical device that received FDA 510(k) clearance on 2025-04-30. It is manufactured by Optain Health, Inc.. The 510(k) number is K250683.

When was Resolve Fundus Camera approved by the FDA?

Resolve Fundus Camera received FDA 510(k) clearance on 2025-04-30, under approval number K250683.

What company makes Resolve Fundus Camera?

Resolve Fundus Camera is manufactured by Optain Health, Inc..

What is the FDA product code for Resolve Fundus Camera?

The FDA product code for Resolve Fundus Camera is HKI.

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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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