The following data is part of a premarket notification filed by Lisa Laser Products Gmbh with the FDA for Revolix Htl.
| Device ID | K211534 |
| 510k Number | K211534 |
| Device Name: | RevoLix HTL |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LISA Laser Products GmbH Albert-Einstein-Str, 4 Katlenburg-Lindau, DE 37191 |
| Contact | Ralf Balkenhol |
| Correspondent | Ralf Balkenhol LISA Laser Products GmbH Albert-Einstein-Str, 4 Katlenburg-Lindau, DE 37191 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-18 |
| Decision Date | 2022-05-19 |