Fundus On Phone Non Mydriatic (FOP NM-10)

FDA 510(k) K252120 · Remidio Innovative Solutions Private Limited

Substantially Equivalent

510(k) numberK252120

Submission

Device name
Fundus On Phone Non Mydriatic (FOP NM-10)
Applicant
Remidio Innovative Solutions Private Limited
Bengaluru, IN
Received
July 7, 2025
Decision date
December 12, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
HKI – Camera, Ophthalmic, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1120
Specialty
Ophthalmic

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Questions and answers

When was Fundus On Phone Non Mydriatic (FOP NM-10) cleared by the FDA?

Fundus On Phone Non Mydriatic (FOP NM-10) (K252120) received a 510(k) decision of Substantially Equivalent on December 12, 2025, 158 days after the submission was received.

What is the product code of K252120?

The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.