Abbott Medical Optics, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Abbott Medical Optics, Inc.” (first 2010, latest 2017), plus 3 PMA decisions, across 8 product codes in 2 review panels. Median 510(k) review time under this name: 129 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 130 |
| 2013 | 0 | — |
| 2014 | 1 | 150 |
| 2015 | 3 | 124 |
| 2016 | 1 | 86 |
| 2017 | 1 | 107 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Abbott Medical Optics, Inc. took a median 107 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 9 | 9 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| HQL | Intraocular Lens | 1 | 0 |
| LPN | Accessories, Soft Lens Products | 1 | 1 |
| LZP | Aid, Surgical, Viscoelastic | 1 | 0 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 1 | 1 |
| OOE | Ophthalmic Femtosecond Laser | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Abbott Medical Optics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170322 | Catalys Precision Laser System | OOE | 2017-05-19 | 107 |
| K160236 | Dual Pump Pack | HQC | 2016-04-27 | 86 |
| K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control | HQC | 2015-10-19 | 124 |
| K151783 | COMPACT INTUITIV Multiple-Use Pack | HQC | 2015-09-02 | 63 |
| K143434 | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series | MSS | 2015-05-06 | 156 |
| K133115 | COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK | HQC | 2014-02-27 | 150 |
| K121721 | LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) | HQC | 2012-10-15 | 125 |
| K113151 | IFS LASER SYSTEM | GEX | 2012-03-08 | 135 |
| K111446 | SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM | HQC | 2011-12-21 | 211 |
| K111882 | LAMINAR FLOW PHACO TIPS | HQC | 2011-11-07 | 129 |
3 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P960034 | PMA | CEEON HEPARIN SURFACE MODIFIED (ASM) ULTRAVIOLET LIGHT. | 1998-08-12 |
| P880070 | PMA | MODEL UV65 ANTERIOR CHAMBER INTRAOCULAR LENS | 1989-09-20 |
| P880031 | PMA | VITRAX SODIUM HYALURONATE | 1989-08-10 |
Recalls
9 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2015-02-20.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Abbott Medical Optics, Inc. is the lead sponsor of 27 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03372434: Clinical Investigation of the Next-Generation Intraocular Lenses (Completed, started 2018-01-16)
- NCT03111550: Clinical Investigation of the Next-Generation Intraocular Lens (Completed, started 2017-05-10)
- NCT02782676: Clinical Investigation of the Bacterially-Derived Healon5 Ophthalmic Viscosurgical Device (OVD) (Completed, started 2016-06-21)
- NCT02649842: Post-Approval Study of the TECNIS® Toric Extended Cylinder Range Intraocular Lens (IOL) (Completed, started 2016-03-21)
- NCT02675751: Prospective S&E Study of Wavefront-guided PRK for Myopia With iDesign Advanced Wavescan Studio™ System and Star S4 IR™ (Completed, started 2016-02-03)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Abbott Laboratories (889 510(k)s)
- ABBOTT MEDICAL (60 510(k)s)
- Abbott Vascular (50 510(k)s)
- Abbott Diabetes Care, Inc. (39 510(k)s)
- Abbott Diagnostics (28 510(k)s)
- Abbott Point of Care, Inc. (22 510(k)s)
- Abbott Molecular, Inc. (18 510(k)s)
- Abbott Mfg., Inc. (14 510(k)s)
- Abbott (13 510(k)s)
- Abbott Spine, Inc. (13 510(k)s)
- Abbott Ireland Diagnostics Division (8 510(k)s)
- Abbott Diagnostics Scarborough, Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Abbott Medical Optics, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Abbott Medical Optics, Inc.” (first 2010, latest 2017), plus 3 PMA decisions, across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Abbott Medical Optics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Abbott Medical Optics, Inc. is 129 days.
Which FDA product codes appear under Abbott Medical Optics, Inc.?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 9); GEX (Powered Laser Surgical Instrument, 1); HQL (Intraocular Lens, 1).
Next steps
- See all 13 Abbott Medical Optics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQC, Abbott Medical Optics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.