BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION
FDA premarket approval P860023/S012 · decided 1997-07-03
Approval details
- PMA number
- P860023
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION
- Generic name
- Accessories, soft lens products
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 1996-11-13
- Decision date
- 1997-07-03
- Days to decision
- 232 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- APPROVAL FOR A CHANGE IN THE FORMULATION AND CORRESPONDING MODIFICATIONS TO THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAUSCH & LOMB RENU MULTIPLUS(TM) MULTI-PURPOSE SOLUTION AND IS INDICATED FOR USE IN THE DAILY CLEANING, PROMOTION OF DAILY PROTEIN REMOVAL, RINSING, CHEMICAL (NOT HEAT) DISINFECTION AND STORAGE OF SOFT (HYDROPHILIC) CONTACT LENSES AS RECOMMENDED BY THE EYE CARE PRACTITIONER.
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510(k) clearances by this applicant
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|---|---|---|
| Bausch + Lomb PreVue Inserter for enVista Preloaded (K192005) | Bausch & Lomb, Inc. | 2019-10-04 |
| Crystalsert Lens Delivery System (K173480) | Bausch & Lomb, Inc. | 2017-12-11 |
| Bausch + Lomb Injector System (K151102) | Bausch & Lomb, Inc. | 2015-05-22 |
| BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, (K131208) | Bausch & Lomb, Inc. | 2013-09-11 |
| BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI (K122575) | Bausch & Lomb, Inc. | 2012-12-20 |
| BAUSCH & LOMB IOL INJECTOR (K113852) | Bausch & Lomb, Inc. | 2012-09-28 |
| OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION (K112909) | Bausch & Lomb, Inc. | 2012-04-30 |
| EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION (K111877) | Bausch & Lomb, Inc. | 2012-01-24 |