FDA product code OOE: Ophthalmic Femtosecond Laser
OOE is the FDA product code for ophthalmic femtosecond laser. It is a Class II device, regulated under 21 CFR 886.4390 and reviewed by the Ophthalmic panel. FDA has cleared 47 510(k) submissions under OOE, 7 in the last five years, from 12 different applicants. The average 510(k) review took 133 days (median 126); 80 days on average over the last three years. FDA has posted 8 recalls for OOE devices, 1 initiated in the last five years.
Definition
Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.
Classification
| Field | Value |
|---|---|
| Device name | Ophthalmic Femtosecond Laser |
| Device class | Class II |
| Regulation | 21 CFR 886.4390 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
510(k) clearances per year for OOE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 6 | 94 |
| 2018 | 5 | 99 |
| 2020 | 2 | 146 |
| 2021 | 1 | 29 |
| 2022 | 3 | 127 |
| 2023 | 2 | 124 |
| 2025 | 2 | 80 |
Compare with all 510(k) review times · Search every OOE clearance
Top OOE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lensar, Inc. | 13 | 2022-06-09 |
| Technolas Perfect Vision GmbH | 9 | 2020-09-01 |
| Alcon Laboratories, Inc. | 5 | 2025-09-24 |
| Amo Manufacturing USA, LLC | 5 | 2023-04-12 |
| Optimedica Corporation | 4 | 2016-09-20 |
7 more applicants have OOE clearances. See the full list in Caduvo.
Most recent OOE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252682 | Alcon Laboratories, Inc. | LenSx Laser System (8065000944) | 2025-09-24 | 30 |
| K243896 | Alcon Laboratories, Inc. | LenSx Laser System (8065998162) | 2025-04-28 | 131 |
| K223566 | Johnson & Johnson Surgical Vision, Inc. | ELITA Femtosecond Laser System, ELITA Patient Interface | 2023-04-14 | 136 |
| K223838 | Amo Manufacturing USA, LLC | Catalys Precision Laser System | 2023-04-12 | 111 |
| K220259 | Lensar, Inc. | ALLY Adaptive Cataract Treatment System | 2022-06-09 | 129 |
Recalls for OOE devices
8 product recalls in 8 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2021-10-21.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code OOE?
OOE is the FDA product code for ophthalmic femtosecond laser. It is a Class II device, regulated under 21 CFR 886.4390 and reviewed by the Ophthalmic panel.
What device class is OOE?
Class II, regulation 21 CFR 886.4390. Typical premarket route: 510(k).
How long does a 510(k) take for product code OOE?
Across 47 cleared submissions the average was 133 days from receipt to decision (median 126).
Which companies have the most OOE clearances?
Lensar, Inc. (13); Technolas Perfect Vision GmbH (9); Alcon Laboratories, Inc. (5); Amo Manufacturing USA, LLC (5); Optimedica Corporation (4).
Have OOE devices been recalled?
Yes: 8 product recalls across 8 recall events; the most recent began 2021-10-21.
Next steps
- Run an FDA pathway report with predicate devices for product code OOE
- Run a recall and safety report across every OOE manufacturer
- Watch product code OOE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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