BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS
FDA premarket approval P980006/S017 · decided 2010-12-27
Approval details
- PMA number
- P980006
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Trade name
- BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2010-12-01
- Decision date
- 2010-12-27
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- REDUCTION OF THE SAMPLE SIZE TESTING PHYSICAL PROPERTIES ACCEPTANCE CRITERIA DURING THE USE OF THE AUTOMATED INSPECTION SYSTEM FOR THE PUREVISION (BALAFILCON A) CONTACT LENSES. THIS CHANGE OF THE SAMPLING PLAN APPLIES ONLY TO BAUSCH & LOMB¿S WATERFORD, IRELAND FACILITY.
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 |