Model 4060 N Nd:Yag Laser for Urological Use
FDA 510(k) K880193 · Sharplan Lasers, Inc.
510(k) numberK880193
Submission
- Device name
- Model 4060 N Nd:Yag Laser for Urological Use
- Applicant
- Sharplan Lasers, Inc.
Allendale, NJ, US - Received
- January 19, 1988
- Decision date
- April 14, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LNK – Laser For Gastro-Urology Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LNK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K925395 | Technomed Pulsolith 4000 Laser SystemLNK · Traditional | Teknomed, Inc. | 05/21/1993SE |
| K901723 | MDL-2000 LasertripterLNK · Traditional | Candela Laser Corp. | 07/13/1990SE |
| K874255 | Nd:Yag Surgical Laser for Endo. Gastro/Uro. Appli.LNK · Traditional | Minnesota Laser Corp. | 07/12/1988SE |
| K874253 | Nd:Yag Surgical Laser for Gastro/Urology Applica.LNK · Traditional | Minnesota Laser Corp. | 07/12/1988SE |
| K880256 | Model 4060 N Nd:Yag Laser for Gastroenterology UseLNK · Traditional | Sharplan Lasers, Inc. | 04/14/1988SE |
| K875039 | Nd:Yag 100 Surgical Laser for Gastro. and UrologyLNK · Traditional | Surgilase, Inc. | 04/13/1988SE |
| K880171 | Model 4900 Nd:Yag Laser for Gastro & Genitour ApplLNK · Traditional | Cooper Lasersonics, Inc. | 04/11/1988SE |
| K871934 | Model 5050 Surgilaser for Gastro-Intestinal UseLNK · Traditional | Lasermatic, Inc. | 03/25/1988SE |
| K871932 | Model 5050 Surgilaser for Urology UseLNK · Traditional | Lasermatic, Inc. | 03/25/1988SE |
| K873892 | Surgi-Light Dispos.Fiberoptic Del/Sys Gi/Uro UseLNK · Traditional | Laserguide | 02/02/1988SE |
More from Laserguide
| 510(k) | Device | Decision |
|---|---|---|
| K973354 | Sharplan Epitouch Alexandrite Laser System (5000)GEX · Traditional | 12/04/1997SE |
| K972099 | Sharplan Epitouch Ruby Laser SystemGEX · Traditional | 08/27/1997SE |
| K971874 | Sharplan Epitouch Alexandrite Laser System (5000)GEX · Traditional | 08/18/1997SE |
| K971648 | Sharplan Erbium: Yag Laser (4020)GEX · Traditional | 07/23/1997SE |
| K971743 | Sharplan CO2 Surgical Laser SystemGEX · Traditional | 07/18/1997SE |
| K962446 | Sharplan Ruby Laser SystemGEX · Traditional | 03/07/1997SE |
| K963229 | Sharplan Models 20C, 30C, and 40C CO2 LasersGEX · Traditional | 11/05/1996SE |
| K961935 | Sharplan Lasers, Inc. Silktouch CO2 Flash ScannerGEX · Traditional | 11/01/1996SE |
| K962974 | Sharplan Lasers, Inc. Af Acuspot Micromanipulator (713)GEX · Traditional | 08/21/1996SE |
| K961279 | Sharplan Lasers, Inc. Ruby Laser SystemGEX · Traditional | 06/18/1996SE |
Questions and answers
When was Model 4060 N Nd:Yag Laser for Urological Use cleared by the FDA?
Model 4060 N Nd:Yag Laser for Urological Use (K880193) received a 510(k) decision of Substantially Equivalent on April 14, 1988, 86 days after the submission was received.
What is the product code of K880193?
The FDA product code is LNK – Laser For Gastro-Urology Use, a Class II (moderate risk) device regulated under 21 CFR 878.4810.