The following data is part of a premarket notification filed by Synergetics, Inc. with the FDA for Scrambled Endooto Laser Probe, Straight Tip, Model 59.02, Scrambled Endooto Laser Probe Bent Tip, Model 59.01.
| Device ID | K990568 |
| 510k Number | K990568 |
| Device Name: | SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SYNERGETICS, INC. 88 HUBBLE DR. St. Charles, MO 63304 -8694 |
| Contact | Kurt W Gampp |
| Correspondent | Kurt W Gampp SYNERGETICS, INC. 88 HUBBLE DR. St. Charles, MO 63304 -8694 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-23 |
| Decision Date | 1999-05-14 |