FDA product code OTL: Femtosecond Laser System For Refractive Correction
OTL is the FDA product code for femtosecond laser system for refractive correction. It is a Class III device, reviewed by the Ophthalmic panel. Devices under OTL reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for OTL devices.
Definition
Ophthalmic femtosecond laser intended to provide refractive vision correction by modification of the shape of the cornea
Classification
| Field | Value |
|---|---|
| Device name | Femtosecond Laser System For Refractive Correction |
| Device class | Class III |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for OTL devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-12-06.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code OTL?
OTL is the FDA product code for femtosecond laser system for refractive correction. It is a Class III device, reviewed by the Ophthalmic panel.
What device class is OTL?
Class III. Typical premarket route: PMA.
Have OTL devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-12-06.
Next steps
- Run an FDA pathway report with predicate devices for product code OTL
- Run a recall and safety report across every OTL manufacturer
- Watch product code OTL 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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