FDA product code LLW: Laser, Neodymium:Yag For Gynecologic Use
LLW is the FDA product code for laser, neodymium:yag for gynecologic use. It is a Class II device, regulated under 21 CFR 884.4550 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under LLW. The average 510(k) review took 9 days (median 9).
Classification
| Field | Value |
|---|---|
| Device name | Laser, Neodymium:Yag For Gynecologic Use |
| Device class | Class II |
| Regulation | 21 CFR 884.4550 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LLW clearance
Top LLW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vital Signs, Inc. | 1 | 1985-02-14 |
Most recent LLW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K850437 | Vital Signs, Inc. | DISPOSABLE LARYNGOSCOPE | 1985-02-14 | 9 |
Recalls for LLW devices
openFDA lists no recalls for product code LLW.
Frequently asked questions
What is FDA product code LLW?
LLW is the FDA product code for laser, neodymium:yag for gynecologic use. It is a Class II device, regulated under 21 CFR 884.4550 and reviewed by the Obstetrics and Gynecology panel.
What device class is LLW?
Class II, regulation 21 CFR 884.4550. Typical premarket route: 510(k).
How long does a 510(k) take for product code LLW?
Across 1 cleared submissions the average was 9 days from receipt to decision (median 9).
Which companies have the most LLW clearances?
Vital Signs, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LLW
- Run a recall and safety report across every LLW manufacturer
- Watch product code LLW 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.
All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times