FDA product code LOI: Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
LOI is the FDA product code for laser, neodymium:yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary. It is a Class III device, reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under LOI. The average 510(k) review took 7 days (median 7). 12 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary |
| Device class | Class III |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | PMA |
Compare with all 510(k) review times · Search every LOI clearance
Top LOI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biophysic Medical, Inc. | 1 | 1988-04-13 |
Most recent LOI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881459 | Biophysic Medical, Inc. | NANOLAS ND:YAG OPHTHALMIC LASER | 1988-04-13 | 7 |
Recalls for LOI devices
openFDA lists no recalls for product code LOI.
Frequently asked questions
What is FDA product code LOI?
LOI is the FDA product code for laser, neodymium:yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary. It is a Class III device, reviewed by the Ophthalmic panel.
What device class is LOI?
Class III. Typical premarket route: PMA.
How long does a 510(k) take for product code LOI?
Across 1 cleared submissions the average was 7 days from receipt to decision (median 7).
Which companies have the most LOI clearances?
Biophysic Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LOI
- Run a recall and safety report across every LOI manufacturer
- Watch product code LOI 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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