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Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus

INTEROJO, Inc.

Summary

INTEROJO, Inc. received 510(k) clearance for Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus, a LPL device. Cleared on 2026-05-29.

Details

Source

510(k) Clearance

External ID

K260507

Action Date

2026-05-29

Status

Traditional

Category

device

Product Code

LPL

Product Description

Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus. Product code: LPL.

Context & Analysis

A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.

Frequently Asked Questions

What does 510(k) clearance mean?

A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.

How often does INTEROJO, Inc. have FDA actions?

This is the only FDA action we have on record for INTEROJO, Inc. in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "K260507" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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