Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus— 510(k) K260507

Substantially Equivalent

INTEROJO, Inc.

FDA 510(k) clearance K260507 for Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus, Substantially Equivalent on 2026-05-29. Applicant: INTEROJO, Inc.. Device class: 2.

Summary

INTEROJO's record is for the Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus. The product code is LPL, daily wear soft contact lenses. The record doesn't describe "GrabSoo Plus" beyond the name.

Class II, 21 CFR 886.5925. Ophthalmic is both the classification panel and the review panel, and the submission was a Traditional 510(k).

INTEROJO filed from Pyeongtaek-Si, South Korea. Review took 101 calendar days (February 17 to May 29, 2026).

Clearance details

Applicant
INTEROJO, Inc.
Product code
Product code LPL
Device class
Class 2
Regulation
21 CFR 886.5925
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pyeongtaek-Si, KR
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LPL

product code LPL
Injury
988
Other
4
Total
992

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.