CRYSTALENS? MODELS AT-50SE AND AT-52SE ACCOMMODATING INTRAOCULAR LENSES (IOLS)
FDA premarket approval P030002/S010 · decided 2007-07-26
Approval details
- PMA number
- P030002
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CRYSTALENS? MODELS AT-50SE AND AT-52SE ACCOMMODATING INTRAOCULAR LENSES (IOLS)
- Generic name
- Lens, intraocular, accommodative
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2007-04-06
- Decision date
- 2007-07-26
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- NAA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE MODELS AT-50SE AND AT-52SE ACCOMMODATING IOLS USED WITH THE STAAR MSI-PF/TF INJECTOR AND MTC-60C CARTRIDGE.
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 |