Laser, Neurosurgical, Argon

Product Code: LLF

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 LLF

3835

Laser, Neurosurgical, Argon

Total Product Life Cycle (TPLC) Devices

3835

Laser, Neurosurgical, Argon

FDA Consensus Standards

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

Pre-market Notifications for LLF

K870773	ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER	HGM, INC.
K864610	CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE	INFRAMED, INC.
K860977	MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION	BRITT CORP., INC.
K833497	COOPER MEDICAL MODEL 770	COOPER MEDICAL CORP.

Maude Adverse Events

ARGON-KRYPTON LASER

ALCON SURGICAL INC.

1992-07-01