The following data is part of a premarket notification filed by Genesis Biosystems, Inc. with the FDA for Accela System.
| Device ID | K081578 |
| 510k Number | K081578 |
| Device Name: | ACCELA SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | GENESIS BIOSYSTEMS, INC. 1500 EAGLE COURT Lewisville, TX 75057 |
| Contact | Stephen J Macdonald |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-06-05 |
| Decision Date | 2008-06-20 |
| Summary: | summary |