FDA product code LLF: Laser, Neurosurgical, Argon
LLF is the FDA product code for laser, neurosurgical, argon. It is a Class III device, reviewed by the Neurology panel. FDA has cleared 4 510(k) submissions under LLF, from 4 different applicants. The average 510(k) review took 187 days (median 200).
Classification
| Field | Value |
|---|---|
| Device name | Laser, Neurosurgical, Argon |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Compare with all 510(k) review times · Search every LLF clearance
Top LLF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hgm, Inc. | 1 | 1987-07-10 |
| Inframed, Inc. | 1 | 1987-06-18 |
| Britt Corp., Inc. | 1 | 1986-10-16 |
| Cooper Medical Corp. | 1 | 1984-04-17 |
Most recent LLF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870773 | Hgm, Inc. | ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER | 1987-07-10 | 134 |
| K864610 | Inframed, Inc. | CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE | 1987-06-18 | 210 |
| K860977 | Britt Corp., Inc. | MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION | 1986-10-16 | 216 |
| K833497 | Cooper Medical Corp. | COOPER MEDICAL MODEL 770 | 1984-04-17 | 189 |
Recalls for LLF devices
openFDA lists no recalls for product code LLF.
Frequently asked questions
What is FDA product code LLF?
LLF is the FDA product code for laser, neurosurgical, argon. It is a Class III device, reviewed by the Neurology panel.
What device class is LLF?
Class III. Typical premarket route: Contact FDA.
How long does a 510(k) take for product code LLF?
Across 4 cleared submissions the average was 187 days from receipt to decision (median 200).
Which companies have the most LLF clearances?
Hgm, Inc. (1); Inframed, Inc. (1); Britt Corp., Inc. (1); Cooper Medical Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LLF
- Run a recall and safety report across every LLF manufacturer
- Watch product code LLF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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