FDA product code LMS: Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
LMS is the FDA product code for laser, microsurgical argon, for uses other than otology, including laryngology & general use in otolaryngology. It is a Class II device, regulated under 21 CFR 874.4490 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under LMS, from 2 different applicants. The average 510(k) review took 99 days (median 99).
Classification
| Field | Value |
|---|---|
| Device name | Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology |
| Device class | Class II |
| Regulation | 21 CFR 874.4490 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LMS clearance
Top LMS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hgm, Inc. | 1 | 1987-07-08 |
| Laserscope | 1 | 1986-04-11 |
Most recent LMS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K871424 | Hgm, Inc. | ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER | 1987-07-08 | 90 |
| K855146 | Laserscope | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL | 1986-04-11 | 108 |
Recalls for LMS devices
openFDA lists no recalls for product code LMS.
Frequently asked questions
What is FDA product code LMS?
LMS is the FDA product code for laser, microsurgical argon, for uses other than otology, including laryngology & general use in otolaryngology. It is a Class II device, regulated under 21 CFR 874.4490 and reviewed by the Ear, Nose and Throat panel.
What device class is LMS?
Class II, regulation 21 CFR 874.4490. Typical premarket route: 510(k).
How long does a 510(k) take for product code LMS?
Across 2 cleared submissions the average was 99 days from receipt to decision (median 99).
Which companies have the most LMS clearances?
Hgm, Inc. (1); Laserscope (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LMS
- Run a recall and safety report across every LMS manufacturer
- Watch product code LMS 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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