The following data is part of a premarket notification filed by Laserguide with the FDA for Light-spot Fiberoptic Laser Handpiece.
| Device ID | K873664 |
| 510k Number | K873664 |
| Device Name: | LIGHT-SPOT FIBEROPTIC LASER HANDPIECE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASERGUIDE 51 SANTA FELICIA DR. SANTA BARBARA, CA 93117 |
| Contact | ROBERT MICHAELS |
| Correspondent | ROBERT MICHAELS LASERGUIDE 51 SANTA FELICIA DR. SANTA BARBARA, CA 93117 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-10 |
| Decision Date | 1987-11-06 |