FDA product code LQJ: Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
LQJ is the FDA product code for lens, surgical, laser, accesssory, ophthalmic laser. It is a Class II device, regulated under 21 CFR 886.4390 and reviewed by the Ophthalmic panel. FDA has cleared 13 510(k) submissions under LQJ, from 7 different applicants. The average 510(k) review took 80 days (median 48). FDA has posted 1 recall for LQJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser |
| Device class | Class II |
| Regulation | 21 CFR 886.4390 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LQJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 175 |
Compare with all 510(k) review times · Search every LQJ clearance
Top LQJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ocular Instruments, Inc. | 6 | 1992-11-16 |
| California Laboratories, Inc. | 2 | 1988-11-30 |
| Katalyst Surgical, LLC | 1 | 2017-06-15 |
| Sorenson Laboratories, Inc. | 1 | 1993-09-07 |
| Tomey Corporation USA | 1 | 1991-06-17 |
2 more applicants have LQJ clearances. See the full list in Caduvo.
Most recent LQJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K163632 | Katalyst Surgical, LLC | Katalyst Cyclophotocoagulation Probe | 2017-06-15 | 175 |
| K931356 | Sorenson Laboratories, Inc. | SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR | 1993-09-07 | 174 |
| K921414 | Ocular Instruments, Inc. | TROKEL /3 GONIO LASER LENS | 1992-11-16 | 237 |
| K912112 | Tomey Corporation USA | PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 | 1991-06-17 | 35 |
| K893731 | Ocular Instruments, Inc. | SHIELDS T.C. LASER LENS | 1989-08-17 | 92 |
Recalls for LQJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-09-02.
Frequently asked questions
What is FDA product code LQJ?
LQJ is the FDA product code for lens, surgical, laser, accesssory, ophthalmic laser. It is a Class II device, regulated under 21 CFR 886.4390 and reviewed by the Ophthalmic panel.
What device class is LQJ?
Class II, regulation 21 CFR 886.4390. Typical premarket route: 510(k).
How long does a 510(k) take for product code LQJ?
Across 13 cleared submissions the average was 80 days from receipt to decision (median 48).
Which companies have the most LQJ clearances?
Ocular Instruments, Inc. (6); California Laboratories, Inc. (2); Katalyst Surgical, LLC (1); Sorenson Laboratories, Inc. (1); Tomey Corporation USA (1).
Have LQJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-09-02.
Next steps
- Run an FDA pathway report with predicate devices for product code LQJ
- Run a recall and safety report across every LQJ manufacturer
- Watch product code LQJ 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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