FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROVIEW EYE PRESSURE MONITOR
K Number: K011199
·
Decision Jul 2, 2001
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
55
Applicant Total
92
Review Days
74
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
- PROVIEW EYE PRESSURE MONITOR
- K Number
- K011199
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bausch & Lomb, Inc.
- Date Received
- April 19, 2001
- Decision Date
- July 2, 2001
- Product Code
- HKY
- 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 |
|---|---|---|---|
| HKY | Tonometer, Manual | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HKY), ordered by most recent decision date.
iCare ST500 (TA04)
FDA 510(k)
FDA Class 2
·Ophthalmic
Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)
FDA 510(k)
FDA Class 2
·Ophthalmic
CATS-L Tonometer Prism
FDA 510(k)
FDA Class 2
·Ophthalmic
Applanation Tonometer HT-5000
FDA 510(k)
FDA Class 2
·Ophthalmic
iCare IC200
FDA 510(k)
FDA Class 2
·Ophthalmic
iCare HOME2
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 |
| K131208 | BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, | Sep 11, 2013 | 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 |