FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
K Number: K251095
·
Decision Sep 17, 2025
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
14
Review Days
160
Basic Information
- Device Name
- Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
- K Number
- K251095
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pegavision Corporation
- Date Received
- April 10, 2025
- Decision Date
- September 17, 2025
- 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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Other Clearances by Pegavision Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K253352 | 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 | May 21, 2026 | Substantially Equivalent |
| K261299 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | May 19, 2026 | Substantially Equivalent |
| K252385 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Mar 13, 2026 | Substantially Equivalent |
| K243868 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Jul 2, 2025 | Substantially Equivalent |
| K232649 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | May 8, 2024 | Substantially Equivalent |
| K222885 | Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) | May 31, 2023 | Substantially Equivalent |
| K211603 | Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses | Feb 2, 2022 | Substantially Equivalent |
| K211448 | Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses | Dec 6, 2021 | Substantially Equivalent |
| K200296 | Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses | Oct 15, 2020 | Substantially Equivalent |
| K161739 | Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | Dec 19, 2016 | Substantially Equivalent |