FDA product code LCC: Applicator, Ocular Pressure
LCC is the FDA product code for applicator, ocular pressure. It is a Class II device, regulated under 21 CFR 886.4610 and reviewed by the Ophthalmic panel. FDA has cleared 6 510(k) submissions under LCC, from 6 different applicants. The average 510(k) review took 86 days (median 74).
Classification
| Field | Value |
|---|---|
| Device name | Applicator, Ocular Pressure |
| Device class | Class II |
| Regulation | 21 CFR 886.4610 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LCC clearance
Top LCC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oryx Medical Pty, Ltd. | 1 | 2012-05-10 |
| Microsurgical Technology, Inc. | 1 | 1995-02-27 |
| Visitec Co. | 1 | 1985-08-12 |
| Surgi-Quip Inc.U | 1 | 1984-03-22 |
| The Lebanon Corp. | 1 | 1982-03-25 |
1 more applicants have LCC clearances. See the full list in Caduvo.
Most recent LCC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K112952 | Oryx Medical Pty, Ltd. | ILWAIT TIMER OCULOPRESSOR | 2012-05-10 | 218 |
| K946194 | Microsurgical Technology, Inc. | WEE BAG O'MERCURY | 1995-02-27 | 69 |
| K852032 | Visitec Co. | OCULAR PRESSURE REDUCER (MCCANNEL) | 1985-08-12 | 95 |
| K840004 | Surgi-Quip Inc.U | WEE BAG O'MERCURY | 1984-03-22 | 78 |
| K820526 | The Lebanon Corp. | RELIEF VALVE-HONAN INTRAOC. PRESSURE | 1982-03-25 | 27 |
Recalls for LCC devices
openFDA lists no recalls for product code LCC.
Frequently asked questions
What is FDA product code LCC?
LCC is the FDA product code for applicator, ocular pressure. It is a Class II device, regulated under 21 CFR 886.4610 and reviewed by the Ophthalmic panel.
What device class is LCC?
Class II, regulation 21 CFR 886.4610. Typical premarket route: 510(k).
How long does a 510(k) take for product code LCC?
Across 6 cleared submissions the average was 86 days from receipt to decision (median 74).
Which companies have the most LCC clearances?
Oryx Medical Pty, Ltd. (1); Microsurgical Technology, Inc. (1); Visitec Co. (1); Surgi-Quip Inc.U (1); The Lebanon Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LCC
- Run a recall and safety report across every LCC manufacturer
- Watch product code LCC 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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