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FDA 510(k)

Fundus On Phone Non Mydriatic (FOP NM-10)

K-Number: K252120 · 2025-12-12

ApplicantRemidio Innovative Solutions Private Limited
Decision Date2025-12-12
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Fundus On Phone Non Mydriatic (FOP NM-10) is the device name listed in this FDA 510(k) record. The listed applicant is Remidio Innovative Solutions Private Limited. It received FDA 510(k) clearance on 2025-12-12 under 510(k) number K252120. 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 Fundus On Phone Non Mydriatic (FOP NM-10)?

Fundus On Phone Non Mydriatic (FOP NM-10) is a medical device that received FDA 510(k) clearance on 2025-12-12. The listed applicant is Remidio Innovative Solutions Private Limited. The 510(k) number is K252120.

When did Fundus On Phone Non Mydriatic (FOP NM-10) receive FDA 510(k) clearance?

Fundus On Phone Non Mydriatic (FOP NM-10) received FDA 510(k) clearance on 2025-12-12, under 510(k) number K252120.

Who is the listed applicant for Fundus On Phone Non Mydriatic (FOP NM-10)?

The FDA 510(k) record lists Remidio Innovative Solutions Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fundus On Phone Non Mydriatic (FOP NM-10)?

The FDA product code for Fundus On Phone Non Mydriatic (FOP NM-10) 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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