The following data is part of a premarket notification filed by Xintec Corporation with the FDA for Optilite Viii Laser Surgery Accessories.
| Device ID | K951760 |
| 510k Number | K951760 |
| Device Name: | OPTILITE VIII LASER SURGERY ACCESSORIES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | XINTEC CORPORATION 900 ALICE ST. Oakland, CA 94607 |
| Contact | Marilyn M Chou |
| Correspondent | Marilyn M Chou XINTEC CORPORATION 900 ALICE ST. Oakland, CA 94607 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-17 |
| Decision Date | 1995-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855430006494 | K951760 | 000 |
| 00855430006692 | K951760 | 000 |
| 00855430006685 | K951760 | 000 |
| 00855430006746 | K951760 | 000 |
| 00855430006739 | K951760 | 000 |
| 00855430006722 | K951760 | 000 |
| 00855430006555 | K951760 | 000 |
| 00855430006548 | K951760 | 000 |
| 00855430006531 | K951760 | 000 |
| 00855430006524 | K951760 | 000 |
| 00855430006517 | K951760 | 000 |
| 00855430006708 | K951760 | 000 |
| 00855430006715 | K951760 | 000 |
| 00855430006449 | K951760 | 000 |
| 00855430006432 | K951760 | 000 |
| 00855430006425 | K951760 | 000 |
| 00855430006302 | K951760 | 000 |
| 00855430006296 | K951760 | 000 |
| 00855430006289 | K951760 | 000 |
| 00855430006272 | K951760 | 000 |
| 00855430006197 | K951760 | 000 |
| 00855430006180 | K951760 | 000 |
| 00855430006173 | K951760 | 000 |
| 00855430006500 | K951760 | 000 |