Laserscope Omni Plus Photosurgical System/Supplem
FDA 510(k) K862598 · Laserscope
510(k) numberK862598
Submission
- Device name
- Laserscope Omni Plus Photosurgical System/Supplem
- Applicant
- Laserscope
Santa Clara, CA, US - Received
- July 1, 1986
- Decision date
- November 19, 1986
- 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 |
| K880193 | Model 4060 N Nd:Yag Laser for Urological 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 |
More from Lasermatic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K062719 | Greenlight HPS Series Surgical Laser System & AccessoriesGEX · Traditional | 12/01/2006SE |
| K061646 | Laserscope Guided Delivery Device (GDD) Cystourethroscope & AccessoriesFBO · Traditional | 06/27/2006SE |
| K034011 | Gemini Surgical Laser System & AccessoriesGEX · Traditional | 03/30/2004SE |
| K024206 | Aura Isurgical Laser System & AccessoriesGEX · Traditional | 11/17/2003SE |
| K020021 | Lyra Surgical Laser System and Accessiories (Nd:Yag Configuration)GEX · Traditional | 07/02/2002SE |
| K010834 | Lyra Series Surgical Laser System & AccessoriesGEX · Traditional | 05/21/2001SE |
| K010284 | Lyra G Series Surgical Laser System (SL Series Q-Switched Nd:Yag Configuration)GEX · Traditional | 05/01/2001SE |
| K003765 | Lyra G Series Surgical Laser System (SL Series Q-Switched Nd:Yag Configuration)GEX · Traditional | 03/06/2001SE |
| K003147 | Lyra Series Surgical Laser System (SL Series, Nd:Yag Configuration)GEX · Traditional | 12/15/2000SE |
| K990718 | Orion Series Surgical Laser System (SL Seriesq-Switched Nd:Yag Configuration)GEX · Traditional | 03/08/2000SE |
Questions and answers
When was Laserscope Omni Plus Photosurgical System/Supplem cleared by the FDA?
Laserscope Omni Plus Photosurgical System/Supplem (K862598) received a 510(k) decision of Substantially Equivalent on November 19, 1986, 141 days after the submission was received.
What is the product code of K862598?
The FDA product code is LNK – Laser For Gastro-Urology Use, a Class II (moderate risk) device regulated under 21 CFR 878.4810.