The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Futurelase 3000/3002 Erbium Laser System.
| Device ID | K974641 |
| 510k Number | K974641 |
| Device Name: | FUTURELASE 3000/3002 ERBIUM LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-15 |
| Decision Date | 1998-06-08 |
| Summary: | summary |