The following data is part of a premarket notification filed by Silhouet-tone Corporation with the FDA for Soli-lite Lg4 Galileo.
| Device ID | K192755 |
| 510k Number | K192755 |
| Device Name: | Soli-Lite LG4 Galileo |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Silhouet-Tone Corporation 2185 Michelin Laval, CA H7l 5b8 |
| Contact | Eric Ghedin |
| Correspondent | Genevieve St-jean Silhouet-Tone Corporation 2185 Rue Michelin Laval, CA H7l 5b8 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00667259003895 | K192755 | 000 |