FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,
K Number: K110452
·
Decision Apr 20, 2011
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
14
Review Days
63
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,
- K Number
- K110452
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Unilens Corp., USA
- Date Received
- February 16, 2011
- Decision Date
- April 20, 2011
- 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
Other 510(k) clearances with the same product code (LPL), ordered by most recent decision date.
Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
FDA 510(k)
FDA Class 2
·Ophthalmic
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
FDA 510(k)
FDA Class 2
·Ophthalmic
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
FDA 510(k)
FDA Class 2
·Ophthalmic
PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Unilens Corp., USA
| K Number | Device Name | ||
|---|---|---|---|
| K142851 | CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens | Oct 30, 2014 | Substantially Equivalent |
| K121652 | CVUE ADVANCED HYDRA VUE | Oct 5, 2012 | Substantially Equivalent |
| K100456 | CVUE ADVANCED DEFINITIVE | Oct 28, 2010 | Substantially Equivalent |
| K082393 | CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | Sep 11, 2008 | Substantially Equivalent |
| K050743 | AQUAFLEX 2 (TEFILCON) CONTACT LENS | Apr 13, 2005 | Substantially Equivalent |
| K041608 | C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS | Jul 7, 2004 | Substantially Equivalent |
| K002408 | AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS | Oct 17, 2000 | Substantially Equivalent |
| K960926 | POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS | Apr 10, 1996 | Substantially Equivalent |
| K960376 | FREESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS | Mar 28, 1996 | Substantially Equivalent |
| K960380 | SEESOFT (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS | Mar 28, 1996 | Substantially Equivalent |