Laser, Neurosurgical

Product Code: LKW

Medical Laser Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations:

• Radiation Type: Optical
• Radition Safety: Product
• Annual Reports: Yes

Products Classified as LKW

3833

Laser, Neurosurgical

Total Product Life Cycle (TPLC) Devices

3833

Laser, Neurosurgical

FDA Consensus Standards

• Laser, Neurosurgical [32410]: 21 CFR Unclassified 🔎
• Laser, Neurosurgical [32150]: 21 CFR Unclassified 🔎

Pre-market Notifications for LKW

K880172	MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA.	COOPER LASERSONICS, INC.
K875042	ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY	SURGILASE, INC.
K864166	25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY	WECK SURGICAL SYSTEMS
K853580	MEDILAS 2	ENDO LASE, INC.
K844440	MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL	COOPER LASERSONICS, INC.

Maude Adverse Events

SNOWDEN PENCER	SNOWDEN PENCER	2005-08-31
NIYAG LASER	NI	2004-11-17