FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
K Number: K131208
·
Decision Sep 11, 2013
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
485
Applicant Total
92
Review Days
135
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
- BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
- K Number
- K131208
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bausch & Lomb, Inc.
- Date Received
- April 29, 2013
- Decision Date
- September 11, 2013
- 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 Bausch & Lomb, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded | Oct 4, 2019 | Substantially Equivalent |
| K173480 | Crystalsert Lens Delivery System | Dec 11, 2017 | Substantially Equivalent |
| K151102 | Bausch + Lomb Injector System | May 22, 2015 | Substantially Equivalent |
| K122575 | BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI | Dec 20, 2012 | Substantially Equivalent |
| K113852 | BAUSCH & LOMB IOL INJECTOR | Sep 28, 2012 | Substantially Equivalent |
| K112909 | OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION | Apr 30, 2012 | Substantially Equivalent |
| K111877 | EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION | Jan 24, 2012 | Substantially Equivalent |
| K112192 | NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS | Oct 25, 2011 | Substantially Equivalent |
| K101325 | STELLARIS PC VISION ENHANCEMENT SYSTEM | Aug 17, 2010 | Substantially Equivalent |
| K083757 | BPZ02 MULTIPURPOSE SOLUTION | Nov 18, 2009 | Substantially Equivalent |