FDA product code LQB: Medical Computers And Software For Ophthalmic Use
LQB is the FDA product code for medical computers and software for ophthalmic use. It is a Class III device, reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under LQB, from 2 different applicants. The average 510(k) review took 260 days (median 260).
Classification
| Field | Value |
|---|---|
| Device name | Medical Computers And Software For Ophthalmic Use |
| Device class | Class III |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Compare with all 510(k) review times · Search every LQB clearance
Top LQB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad | 1 | 1993-08-03 |
| Oculab, Inc. | 1 | 1986-04-24 |
Most recent LQB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K922590 | Bio-Rad | BIO-PEN SRK II CALCULATOR | 1993-08-03 | 427 |
| K860205 | Oculab, Inc. | BIO-PEN CALCULATOR | 1986-04-24 | 92 |
Recalls for LQB devices
openFDA lists no recalls for product code LQB.
Frequently asked questions
What is FDA product code LQB?
LQB is the FDA product code for medical computers and software for ophthalmic use. It is a Class III device, reviewed by the Ophthalmic panel.
What device class is LQB?
Class III. Typical premarket route: Contact FDA.
How long does a 510(k) take for product code LQB?
Across 2 cleared submissions the average was 260 days from receipt to decision (median 260).
Which companies have the most LQB clearances?
Bio-Rad (1); Oculab, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LQB
- Run a recall and safety report across every LQB manufacturer
- Watch product code LQB 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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