# K260507: Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus

- Pathway: 510(k) (Traditional)
- Applicant: INTEROJO, Inc.
- Decided: May 29, 2026 after 101 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960926 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131208: Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon a) Contact Lens for Presbyopia,, Bausch & Lomb, Inc. (2013) Summary page 6.

## Indications for use
The Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 0.75 diopters or less, that does not interfere with visual acuity. The daily wear lens may be prescribed for monthly replacement in powers ranging from +15.00D to -20.00D. The Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus for Astigmatism is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 4.00 diopters, that does not interfere with visual acuity. The daily wear lens may be prescribed for monthly replacement in powers ranging from +6.OOD to -12.00D. The Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus for Presbyopia is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 0.75 diopters or less, that does not interfere with visual acuity. The daily wear lens may be prescribed for monthly replacement in a power range of +6.00 to -12.00 diopters with add power ranging from +1.00D to +4.00D. The Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye. The lens may be disinfected using a chemical disinfection system and should be discarded after one month of use or according to the recommended wearing period prescribed by the eye care practitioner.

Source page: https://510kreport.com/device/K260507
Methodology: https://510kreport.com/methodology