FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
K Number: K020802
·
Decision May 31, 2002
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
21
Applicant Total
9
Review Days
80
Basic Information
- Device Name
- RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
- K Number
- K020802
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BAUSCH & LOMB INCORPORATED
- Date Received
- March 12, 2002
- Decision Date
- May 31, 2002
- Product Code
- LYL
- 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 |
|---|---|---|---|
| LYL | Accessories, Solution, Ultrasonic Cleaners For Lenses | FDA class 2 | Ophthalmic |
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| K Number | Device Name | ||
|---|---|---|---|
| K151918 | Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist | Feb 11, 2016 | Substantially Equivalent |
| K132715 | BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS | Dec 20, 2013 | Substantially Equivalent |
| K132216 | BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION | Sep 9, 2013 | Substantially Equivalent |
| K113703 | BAUSCH + LOMB NESOFILCON A CONTACT LENS | Jun 5, 2012 | Substantially Equivalent |
| K053124 | BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES | Jan 30, 2006 | Substantially Equivalent |
| K024289 | BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION | May 2, 2003 | Substantially Equivalent |
| K022128 | BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS | Aug 22, 2002 | Substantially Equivalent |
| K013762 | RIGID GAS PERMEABLE CONTACT LENS | Apr 3, 2002 | Substantially Equivalent |