The following data is part of a premarket notification filed by Lasermed, Inc. with the FDA for Accucure 1000.
| Device ID | K970637 |
| 510k Number | K970637 |
| Device Name: | ACCUCURE 1000 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASERMED, INC. 3675 WEST 1987 SOUTH Salt Lake City, UT 84104 |
| Contact | Calvin D Ostler |
| Correspondent | Calvin D Ostler LASERMED, INC. 3675 WEST 1987 SOUTH Salt Lake City, UT 84104 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-20 |
| Decision Date | 1997-04-02 |