LKWClass III

Laser, Neurosurgical

Unknown

LKW is the FDA product code for Laser, Neurosurgical, a class III device type. As of 2026-09-10, FDA records hold 5 510(k) clearances under this code, the most recent dated 1988-06-24, and no recalls.

Classification record

Product code: LKW
Device name: Laser, Neurosurgical
Device class: Class III
Review panel: Unknown
Submission type: Contact ODE
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 5
Ingested recalls: 0

Clearances, product code LKW

By decision year

5 clearances under product code LKW with a decision year between 1985 and 1988, 1988 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code LKW by decision year
Year	Clearances
1985	1
1986	1
1987	1
1988	2

Applicants with the most clearances

Product code LKW

Applicants holding the most 510(k) clearances under product code LKW
Applicant	Clearances
Cooper Lasersonics, Inc.	2
Endo Lase, Inc.	1
Surgilase, Inc.	1
Weck Surgical Systems	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LKW.

Recent clearances

Product code LKW

Recent recalls

Product code LKW

FDA records show no recalls under product code LKW.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)