Product Code: LLF
FDA class 3
Laser, Neurosurgical, Argon
Unknown
Laser, Neurosurgical, Argon is an argon-gas laser system designed for use in neurosurgical applications, used to coagulate, cut, or ablate neural tissue with high precision in procedures involving the brain or spinal cord. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness. The product code is LLF; no regulation number has been assigned. The review panel is Neurology.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
4
Years Active
3
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Basic Information
- Product Code
- LLF
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- NE
- Submission Type
- 3
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K870773 | ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER | Jul 10, 1987 | Substantially Equivalent | Hgm, Inc. |
| K864610 | CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE | Jun 18, 1987 | Substantially Equivalent | Inframed, Inc. |
| K860977 | MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION | Oct 16, 1986 | Substantially Equivalent | Britt Corp., Inc. |
| K833497 | COOPER MEDICAL MODEL 770 | Apr 17, 1984 | Substantially Equivalent | Cooper Medical Corp. |