FDA product code LLO: Laser, Neodymium:Yag, Pulmonary Surgery
LLO is the FDA product code for laser, neodymium:yag, pulmonary surgery. It is a Class II device, regulated under 21 CFR 874.4500 and reviewed by the Anesthesiology panel. FDA has cleared 19 510(k) submissions under LLO, from 15 different applicants. The average 510(k) review took 77 days (median 46).
Classification
| Field | Value |
|---|---|
| Device name | Laser, Neodymium:Yag, Pulmonary Surgery |
| Device class | Class II |
| Regulation | 21 CFR 874.4500 |
| Review panel | AN — Anesthesiology |
| 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 LLO clearance
Top LLO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cooper Lasersonics, Inc. | 3 | 1988-03-24 |
| Surgical Laser Technologies, Inc. | 2 | 1988-12-22 |
| Laser Media | 2 | 1987-12-11 |
| Surgilase, Inc. | 1 | 1988-04-29 |
| Laser Peripherals, LLC | 1 | 1988-04-25 |
10 more applicants have LLO clearances. See the full list in Caduvo.
Most recent LLO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884815 | Surgical Laser Technologies, Inc. | SLT CLMD CONTACT LASER | 1988-12-22 | 35 |
| K881499 | Surgilase, Inc. | SURGILASE YAG 100 FOR GYNECOLOGY USE | 1988-04-29 | 38 |
| K880592 | Laser Peripherals, LLC | LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE | 1988-04-25 | 74 |
| K880170 | Cooper Lasersonics, Inc. | MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS | 1988-03-24 | 69 |
| K874254 | Minnesota Laser Corp. | ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS | 1988-03-04 | 136 |
Recalls for LLO devices
openFDA lists no recalls for product code LLO.
Frequently asked questions
What is FDA product code LLO?
LLO is the FDA product code for laser, neodymium:yag, pulmonary surgery. It is a Class II device, regulated under 21 CFR 874.4500 and reviewed by the Anesthesiology panel.
What device class is LLO?
Class II, regulation 21 CFR 874.4500. Typical premarket route: 510(k).
How long does a 510(k) take for product code LLO?
Across 19 cleared submissions the average was 77 days from receipt to decision (median 46).
Which companies have the most LLO clearances?
Cooper Lasersonics, Inc. (3); Surgical Laser Technologies, Inc. (2); Laser Media (2); Surgilase, Inc. (1); Laser Peripherals, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LLO
- Run a recall and safety report across every LLO manufacturer
- Watch product code LLO 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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