Fiberlase 100 Medical Laser System
FDA 510(k) K852798 · Laser Media
510(k) numberK852798
Submission
- Device name
- Fiberlase 100 Medical Laser System
- Applicant
- Laser Media
Hauppauge, NY, US - Received
- July 1, 1985
- Decision date
- July 29, 1985
- 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 |
|---|---|---|
| K872352 | Fiberlase II Nd:Yag Laser for Treat of MenorrhagiaHHR · Traditional | 12/30/1987SE |
| K872351 | Fiberlase II Nd:Yag Laser for Pulmonary UseLLO · Traditional | 12/11/1987SE |
| K872350 | Fiberlase II Nd:Yag Laser for Gastro.&Urology UseLNK · Traditional | 08/10/1987SE |
| K872031 | Uni-Fiber Non-Repairable Fiber Delivery SystemLNK · Traditional | 08/04/1987SE |
| K863428 | Single Use Laser Fiber Delivery System for ND: YagLNK · Traditional | 12/03/1986SE |
| K863583 | Change in Fiberlase 100 Nd:Yag Medical LaserLNK · Traditional | 11/24/1986SE |
| K862444 | Fiberlase 100 Medical Laser Sys/Nd:Yag MenorrhagiaHHR · Traditional | 09/25/1986SE |
| K860063 | Nd:Yag Laser Single Use Fiber Delivery SystemLNK · Traditional | 02/05/1986SE |
| K855197 | Fiberlase 100 ND: Yag Medical Laser SystemLNK · Traditional | 01/21/1986SE |
| K850509 | Nd:Yag Fiberlase 100 Medical Laser SystemLNK · Traditional | 04/08/1985SE |
Questions and answers
When was Fiberlase 100 Medical Laser System cleared by the FDA?
Fiberlase 100 Medical Laser System (K852798) received a 510(k) decision of Substantially Equivalent on July 29, 1985, 28 days after the submission was received.
What is the product code of K852798?
The FDA product code is LNK – Laser For Gastro-Urology Use, a Class II (moderate risk) device regulated under 21 CFR 878.4810.