FDA product code LKW: Laser, Neurosurgical
LKW is the FDA product code for laser, neurosurgical. It is a Class III device, reviewed by the Neurology panel. FDA has cleared 5 510(k) submissions under LKW, from 4 different applicants. The average 510(k) review took 142 days (median 171).
Classification
| Field | Value |
|---|---|
| Device name | Laser, Neurosurgical |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Compare with all 510(k) review times · Search every LKW clearance
Top LKW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cooper Lasersonics, Inc. | 2 | 1988-03-11 |
| Surgilase, Inc. | 1 | 1988-06-24 |
| Weck Surgical Systems | 1 | 1987-02-10 |
| Endo Lase, Inc. | 1 | 1986-02-13 |
Most recent LKW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K875042 | Surgilase, Inc. | ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY | 1988-06-24 | 200 |
| K880172 | Cooper Lasersonics, Inc. | MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. | 1988-03-11 | 56 |
| K864166 | Weck Surgical Systems | 25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY | 1987-02-10 | 110 |
| K853580 | Endo Lase, Inc. | MEDILAS 2 | 1986-02-13 | 171 |
| K844440 | Cooper Lasersonics, Inc. | MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL | 1985-05-09 | 174 |
Recalls for LKW devices
openFDA lists no recalls for product code LKW.
Frequently asked questions
What is FDA product code LKW?
LKW is the FDA product code for laser, neurosurgical. It is a Class III device, reviewed by the Neurology panel.
What device class is LKW?
Class III. Typical premarket route: Contact FDA.
How long does a 510(k) take for product code LKW?
Across 5 cleared submissions the average was 142 days from receipt to decision (median 171).
Which companies have the most LKW clearances?
Cooper Lasersonics, Inc. (2); Surgilase, Inc. (1); Weck Surgical Systems (1); Endo Lase, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LKW
- Run a recall and safety report across every LKW manufacturer
- Watch product code LKW 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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