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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 the device name listed in this FDA 510(k) record. The listed applicant is Optain Health, Inc.. It received FDA 510(k) clearance on 2025-04-30 under 510(k) 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. The listed applicant is Optain Health, Inc.. The 510(k) number is K250683.

When did Resolve Fundus Camera receive FDA 510(k) clearance?

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

Who is the listed applicant for Resolve Fundus Camera?

The FDA 510(k) record lists Optain Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Resolve Fundus Camera?

The FDA product code for Resolve Fundus Camera is HKI.

Related Devices (Code: HKI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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