Medical Device Manufacturer · US , Inwood , NY

Ote North America, LLC - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2021

Total

Cleared

Denied

Ote North America, LLC has 1 FDA 510(k) cleared medical devices. Based in Inwood, US.

Last cleared in 2021. Active since 2021. Primary specialty: Ophthalmic.

Browse the FDA 510(k) cleared devices submitted by Ote North America, LLC Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Foresight Regulatory Strategies, Inc. as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Ote North America, LLC

1 devices

1-1 of 1

Cleared CT May 26, 2021

OTE MPS 045 Multi-purpose Lens Care Solution

K210051 · LPN

Ophthalmic · 138d

Regulatory Intelligence

Linked clinical trials FDA-regulated device evidence

Regulatory consultant 510(k) submission support ecosystem

Foresight Regulatory Strategies, Inc.

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Clinical validation data available

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 25, 2026

Ote North America, LLC - FDA 510(k) Cleared Devices

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