Surgi-Light Nd:Yag Laser for Urological Use
FDA 510(k) K880071 · Laserguide
510(k) numberK880071
Submission
- Device name
- Surgi-Light Nd:Yag Laser for Urological Use
- Applicant
- Laserguide
Santa Barbara, CA, US - Received
- January 11, 1988
- Decision date
- March 22, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FCS – Light, Catheter, Fiberoptic, Glass, Ureteral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4020
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FCS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K151243 | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]FCS · Traditional | Stryker Endoscopy | 08/20/2015SE |
| K061548 | Stryker Ureteral Illumination System IVFCS · Traditional | Stryker Corp. | 09/28/2006SE |
| K982542 | Stryker Ureteral Illuminator System IIIFCS · Traditional | Stryker Endoscopy | 09/22/1998SE |
| K943801 | Uriglow Transilluminating Ureteric Stent ModelFCS · Traditional | Rocket of London, Ltd. | 08/15/1995SE |
| K945088 | Gabriel Ureteral Illuminator System IIFCS · Traditional | Gabriel Medical, Inc. | 02/07/1995SE |
| K941506 | Ureteral IlluminatorFCS · Traditional | Apple Medical Corp. | 10/05/1994SE |
| K940019 | Gabriel Ureteral Illuminator SystemFCS · Traditional | Gabriel Medical, Inc. | 05/02/1994SE |
| K923436 | Illuminated Ureteral CatheterFCS · Traditional | Cook Urological, Inc. | 03/05/1993SE |
| K874680 | Laseguide 600A, 600B, 400A, and 400BFCS · Traditional | Laser Peripherals, LLC | 03/23/1988SE |
More from Laser Peripherals, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K875104 | Surgi-Light Disposable System for Pulmonology UseLLO · Traditional | 02/02/1988SE |
| K873892 | Surgi-Light Dispos.Fiberoptic Del/Sys Gi/Uro UseLNK · Traditional | 02/02/1988SE |
| K873664 | Light-Spot Fiberoptic Laser HandpieceGEX · Traditional | 11/06/1987SE |
| K873571 | Light-Touch Fiberoptic Microcontact ProbeGEX · Traditional | 11/06/1987SE |
Questions and answers
When was Surgi-Light Nd:Yag Laser for Urological Use cleared by the FDA?
Surgi-Light Nd:Yag Laser for Urological Use (K880071) received a 510(k) decision of Substantially Equivalent on March 22, 1988, 71 days after the submission was received.
What is the product code of K880071?
The FDA product code is FCS – Light, Catheter, Fiberoptic, Glass, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.4020.