FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear
K Number: K142766
·
Decision Mar 12, 2015
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
4
Review Days
168
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Basic Information
- Device Name
- I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear
- K Number
- K142766
- 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
- September 25, 2014
- Decision Date
- March 12, 2015
- 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 |
Similar 510(k) Clearances
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Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
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FDA Class 2
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Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
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Other Clearances by INTEROJO, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260507 | Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus | May 29, 2026 | Substantially Equivalent |
| 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 |