FDA product code PUL: Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
PUL is the FDA product code for apparatus, cutting, radiofrequency, electrosurgical, ac-powered. It is a Class II device, regulated under 21 CFR 886.4100 and reviewed by the Ophthalmic panel. FDA has cleared 4 510(k) submissions under PUL, 2 in the last five years, from 2 different applicants. The average 510(k) review took 134 days (median 104).
Definition
Used to perform anterior capsulotomy during cataract surgery
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.4100 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
510(k) clearances per year for PUL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 91 |
| 2021 | 1 | 270 |
| 2022 | 1 | 59 |
| 2023 | 1 | 117 |
Compare with all 510(k) review times · Search every PUL clearance
Top PUL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Centricity Vision, Inc. | 3 | 2023-04-11 |
| Mynosys Cellular Devices, Inc. | 1 | 2017-06-02 |
Most recent PUL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223763 | Centricity Vision, Inc. | ZeptoLink IOL Positioning System | 2023-04-11 | 117 |
| K221188 | Centricity Vision, Inc. | ZEPTO Precision Capsulotomy System | 2022-06-23 | 59 |
| K210827 | Centricity Vision, Inc. | ZEPTO Precision Capsulotomy System | 2021-12-14 | 270 |
| K170655 | Mynosys Cellular Devices, Inc. | Zepto | 2017-06-02 | 91 |
Recalls for PUL devices
openFDA lists no recalls for product code PUL.
Frequently asked questions
What is FDA product code PUL?
PUL is the FDA product code for apparatus, cutting, radiofrequency, electrosurgical, ac-powered. It is a Class II device, regulated under 21 CFR 886.4100 and reviewed by the Ophthalmic panel.
What device class is PUL?
Class II, regulation 21 CFR 886.4100. Typical premarket route: 510(k).
How long does a 510(k) take for product code PUL?
Across 4 cleared submissions the average was 134 days from receipt to decision (median 104).
Which companies have the most PUL clearances?
Centricity Vision, Inc. (3); Mynosys Cellular Devices, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PUL
- Run a recall and safety report across every PUL manufacturer
- Watch product code PUL 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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