The following data is part of a premarket notification filed by Xintec Corporation with the FDA for Optilite Fiberoptic Delivery Systems.
| Device ID | K902871 |
| 510k Number | K902871 |
| Device Name: | OPTILITE FIBEROPTIC DELIVERY SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | XINTEC CORPORATION 1963 ROCK ST. SUITE #17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose XINTEC CORPORATION 1963 ROCK ST. SUITE #17 Mountain View, CA 94043 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-29 |
| Decision Date | 1990-09-24 |