SL-100 Nd:Yag Laser for Rectal Patho. & Hemorrhoid
FDA 510(k) K871514 · Medical Energy, Inc.
510(k) numberK871514
Submission
- Device name
- SL-100 Nd:Yag Laser for Rectal Patho. & Hemorrhoid
- Applicant
- Medical Energy, Inc.
Pensacola, FL, US - Received
- April 20, 1987
- Decision date
- July 9, 1987
- 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 |
|---|---|---|
| K041419 | Lightforce LF 20/30 980NM Surgical Diode Laser SystemGEX · Traditional | 08/26/2004SE |
| K871512 | SL-100 Nd:Yag Laser for Gynecology UseGEX · Traditional | 07/08/1988SE |
| K871511 | SL-100 Nd:Yag Laser for Pulmonary ObstructionsLLO · Traditional | 07/21/1987SE |
| K871516 | SL-100 Nd:Yag Laser for Urologic SurgeryLNK · Traditional | 07/09/1987SE |
| K871515 | SL-100 Nd:Yag Laser for Gastrointestinal BleedingLNK · Traditional | 07/09/1987SE |
| K871513 | SL-100 Nd:Yag Laser for Palliation of Gastro. MaliLNK · Traditional | 07/09/1987SE |
Questions and answers
When was SL-100 Nd:Yag Laser for Rectal Patho. & Hemorrhoid cleared by the FDA?
SL-100 Nd:Yag Laser for Rectal Patho. & Hemorrhoid (K871514) received a 510(k) decision of Substantially Equivalent on July 9, 1987, 80 days after the submission was received.
What is the product code of K871514?
The FDA product code is LNK – Laser For Gastro-Urology Use, a Class II (moderate risk) device regulated under 21 CFR 878.4810.