The following data is part of a premarket notification filed by Laserguide with the FDA for Surgi-light Nd:yag Laser For Urological Use.
| Device ID | K880071 |
| 510k Number | K880071 |
| Device Name: | SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE |
| Classification | Light, Catheter, Fiberoptic, Glass, Ureteral |
| Applicant | LASERGUIDE 51 SANTA FELICIA DR. Santa Barbara, CA 93117 |
| Contact | Pamela Gorforth |
| Correspondent | Pamela Gorforth LASERGUIDE 51 SANTA FELICIA DR. Santa Barbara, CA 93117 |
| Product Code | FCS |
| CFR Regulation Number | 876.4020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-11 |
| Decision Date | 1988-03-22 |