FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)
K Number: K182247
·
Decision Oct 12, 2018
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
5
Review Days
53
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Basic Information
- Device Name
- ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)
- K Number
- K182247
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vizionfocus, Inc.
- Date Received
- August 20, 2018
- Decision Date
- October 12, 2018
- 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 Vizionfocus, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251573 | VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens | Sep 10, 2025 | Substantially Equivalent |
| K243953 | Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) | Apr 10, 2025 | Substantially Equivalent |
| K242413 | VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens | Dec 17, 2024 | Substantially Equivalent |
| K192225 | Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses | Dec 9, 2019 | Substantially Equivalent |