FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
K Number: K260507
·
Decision May 29, 2026
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
4
Review Days
101
Basic Information
- Device Name
- Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
- K Number
- K260507
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- INTEROJO, Inc.
- Date Received
- February 17, 2026
- Decision Date
- May 29, 2026
- Product Code
- LPL
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | FDA class 2 | Ophthalmic |
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Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses
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Other Clearances by INTEROJO, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K221517 | POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens | Oct 4, 2022 | Substantially Equivalent |
| K153766 | Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear | Apr 8, 2016 | Substantially Equivalent |
| K142766 | I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear | Mar 12, 2015 | Substantially Equivalent |