FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
K Number: K180819
·
Decision May 16, 2018
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
17
Review Days
48
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Basic Information
- Device Name
- One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
- K Number
- K180819
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Menicon Co, Ltd.
- Date Received
- March 29, 2018
- Decision Date
- May 16, 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 Menicon Co, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K193399 | Miru 1day UpSide (midafilcon A) | Jun 17, 2020 | Substantially Equivalent |
| K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution | Mar 2, 2020 | Substantially Equivalent |
| K180004 | Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens | Feb 22, 2018 | Substantially Equivalent |
| K173136 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses | Nov 16, 2017 | Substantially Equivalent |
| K151768 | Menicon Saline Rinse Solution | Aug 28, 2015 | Substantially Equivalent |
| K130805 | MENICON UNIQUE PH MULTI-PURPOSE SOLUTION | Jul 3, 2013 | Substantially Equivalent |
| K122273 | MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS | Jan 2, 2013 | Substantially Equivalent |
| K102895 | ONE DAY FLAT PACK | Apr 28, 2011 | Substantially Equivalent |
| K103561 | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS | Feb 3, 2011 | Substantially Equivalent |
| K082855 | MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES | Mar 9, 2010 | Substantially Equivalent |