BAUSCH & LOMB PUREVISION2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES, BASUCH & LOMB PUREVISION2 MULTI-FOCAL (BALAFI
FDA premarket approval P980006/S022 · decided 2014-07-11
Approval details
- PMA number
- P980006
- Supplement
- S022
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BAUSCH & LOMB PUREVISION2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES, BASUCH & LOMB PUREVISION2 MULTI-FOCAL (BALAFI
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2014-04-14
- Decision date
- 2014-07-11
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR THE ADDITION OF THE FOLLOWING PRIVATE LABEL TRADE NAMES: EQUATE MONTHLY SINGLE VISION (BALAFILCON A) CONTACT LENS, EQUATE MONTHLY MULTI-FOCAL (BALAFILCON A) CONTACT LENS, EQUATE MONTHLY TORIC (BALAFILCON A) CONTACT LENSES, AND C-VUE ADDVANTAGE MULTIFOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE EQUATE MONTHLY SINGLE VISION (BALAFILCON A) CONTACT LENS AND IS INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |