The following data is part of a premarket notification filed by Xintec Corporation with the FDA for Odyssey Ho:yag Surgical Laser Systems & Accessories.
| Device ID | K951910 |
| 510k Number | K951910 |
| Device Name: | ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & 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 | 1995-04-24 |
| Decision Date | 1995-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855430006395 | K951910 | 000 |
| 00855430006135 | K951910 | 000 |
| 00855430006128 | K951910 | 000 |
| 00855430006111 | K951910 | 000 |
| 00855430006036 | K951910 | 000 |
| 00855430006029 | K951910 | 000 |
| 00855430006012 | K951910 | 000 |
| 00855430006005 | K951910 | 000 |
| 00855430006678 | K951910 | 000 |
| 00855430006661 | K951910 | 000 |
| 00855430006654 | K951910 | 000 |
| 00855430006647 | K951910 | 000 |
| 00855430006630 | K951910 | 000 |
| 00855430006623 | K951910 | 000 |
| 00855430006616 | K951910 | 000 |
| 00855430006609 | K951910 | 000 |
| 00855430006142 | K951910 | 000 |
| 00855430006159 | K951910 | 000 |
| 00855430006166 | K951910 | 000 |
| 00855430006388 | K951910 | 000 |
| 00855430006371 | K951910 | 000 |
| 00855430006364 | K951910 | 000 |
| 00855430006357 | K951910 | 000 |
| 00855430006340 | K951910 | 000 |
| 00855430006333 | K951910 | 000 |
| 00855430006326 | K951910 | 000 |
| 00855430006319 | K951910 | 000 |
| 00855430006265 | K951910 | 000 |
| 00855430006258 | K951910 | 000 |
| 00855430006241 | K951910 | 000 |
| 00855430006234 | K951910 | 000 |
| 00855430006227 | K951910 | 000 |
| 00855430006210 | K951910 | 000 |
| 00855430006203 | K951910 | 000 |
| 00855430006593 | K951910 | 000 |