FDA product code LNK: Laser For Gastro-Urology Use
LNK is the FDA product code for laser for gastro-urology use. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 60 510(k) submissions under LNK, from 22 different applicants. The average 510(k) review took 98 days (median 80).
Classification
| Field | Value |
|---|---|
| Device name | Laser For Gastro-Urology Use |
| Device class | Class II |
| Regulation | 21 CFR 878.4810 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LNK clearance
Top LNK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cooper Lasersonics, Inc. | 8 | 1988-04-11 |
| Laser Media | 8 | 1987-08-10 |
| Endo Lase, Inc. | 6 | 1986-02-05 |
| Sharplan Lasers, Inc. | 4 | 1988-04-14 |
| Medical Energy, Inc. | 4 | 1987-07-09 |
17 more applicants have LNK clearances. See the full list in Caduvo.
Most recent LNK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K925395 | Teknomed, Inc. | TECHNOMED PULSOLITH 4000 LASER SYSTEM | 1993-05-21 | 207 |
| K901723 | Candela Laser Corp. | MDL-2000 LASERTRIPTER | 1990-07-13 | 88 |
| K874255 | Minnesota Laser Corp. | ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. | 1988-07-12 | 266 |
| K874253 | Minnesota Laser Corp. | ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. | 1988-07-12 | 266 |
| K880256 | Sharplan Lasers, Inc. | MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE | 1988-04-14 | 85 |
Recalls for LNK devices
openFDA lists no recalls for product code LNK.
Frequently asked questions
What is FDA product code LNK?
LNK is the FDA product code for laser for gastro-urology use. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the Gastroenterology and Urology panel.
What device class is LNK?
Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).
How long does a 510(k) take for product code LNK?
Across 60 cleared submissions the average was 98 days from receipt to decision (median 80).
Which companies have the most LNK clearances?
Cooper Lasersonics, Inc. (8); Laser Media (8); Endo Lase, Inc. (6); Sharplan Lasers, Inc. (4); Medical Energy, Inc. (4).
Next steps
- Run an FDA pathway report with predicate devices for product code LNK
- Run a recall and safety report across every LNK manufacturer
- Watch product code LNK 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 Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times