Technomed Pulsolith 4000 Laser System
FDA 510(k) K925395 · Teknomed, Inc.
510(k) numberK925395
Submission
- Device name
- Technomed Pulsolith 4000 Laser System
- Applicant
- Teknomed, Inc.
Danvers, MA, US - Received
- October 26, 1992
- Decision date
- May 21, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K873892 | Surgi-Light Dispos.Fiberoptic Del/Sys Gi/Uro UseLNK · Traditional | Laserguide | 02/02/1988SE |
More from Laserguide
| 510(k) | Device | Decision |
|---|---|---|
| K920708 | Multilase 2500 aGEX · Traditional | 11/05/1992SE |
| K913917 | Multilase 2100 C, 2100 DGEX · Traditional | 11/05/1992SE |
| K913290 | Multilase 2100 aGEX · Traditional | 02/21/1992SE |
| K895178 | Technomed Pulsolith Laser SystemFFK · Traditional | 10/06/1989SE |
| K890436 | Technomed Pulsolith Laser SystemFFK · Traditional | 03/23/1989SE |
| K790132 | TecnotomoIZF · Traditional | 02/21/1979SE |
Questions and answers
When was Technomed Pulsolith 4000 Laser System cleared by the FDA?
Technomed Pulsolith 4000 Laser System (K925395) received a 510(k) decision of Substantially Equivalent on May 21, 1993, 207 days after the submission was received.
What is the product code of K925395?
The FDA product code is LNK – Laser For Gastro-Urology Use, a Class II (moderate risk) device regulated under 21 CFR 878.4810.