The following data is part of a premarket notification filed by Innovoyce Llc with the FDA for Innovoyce Laser Fiber.
| Device ID | K220793 |
| 510k Number | K220793 |
| Device Name: | InnoVoyce Laser Fiber |
| Classification | Powered Laser Surgical Instrument |
| Applicant | InnoVoyce LLC 25 Dorchester Avenue, Ste #52318 Boston, MA 02205 |
| Contact | Kent Johnson |
| Correspondent | Cori Ragan Labcorp 5353 Wayzata Boulevard, Suite 505 Minneapolis, MN 55416 -1334 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-18 |
| Decision Date | 2022-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860004755975 | K220793 | 000 |
| 00860004755968 | K220793 | 000 |
| 00860004755951 | K220793 | 000 |