Product code LKW— Unknown

FDA has cleared 5 devices under product code LKW between 1985 and 1988, filed by 4 applicant companies. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.

• 19882 clearances
• 19871 clearance
• 19861 clearance
• 19851 clearance

• Cooper Lasersonics, Inc.2 clearances
• Weck Surgical Systems1 clearance
• Surgilase, Inc.1 clearance
• Endo Lase, Inc.1 clearance

• K875042 — ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARYSurgilase, Inc.·1988-06-24
• K880172 — MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA.Cooper Lasersonics, Inc.·1988-03-11
• K864166 — 25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGYWeck Surgical Systems·1987-02-10
• K853580 — MEDILAS 2Endo Lase, Inc.·1986-02-13
• K844440 — MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROLCooper Lasersonics, Inc.·1985-05-09