The following data is part of a premarket notification filed by Innovaquartz with the FDA for Innovaquartz General Shape Laser Fiber.
| Device ID | K994010 |
| 510k Number | K994010 |
| Device Name: | INNOVAQUARTZ GENERAL SHAPE LASER FIBER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INNOVAQUARTZ 4420 SOUTH 32ND ST. Phoenix, AZ 85040 |
| Contact | Randy Mclellan |
| Correspondent | Randy Mclellan INNOVAQUARTZ 4420 SOUTH 32ND ST. Phoenix, AZ 85040 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-26 |
| Decision Date | 1999-12-17 |