The following data is part of a premarket notification filed by Leaseir Technologies S.l.u. with the FDA for Leaseir Mhr Xcell.
| Device ID | K214049 |
| 510k Number | K214049 |
| Device Name: | Leaseir MHR Xcell |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Leaseir Technologies S.L.U. C/ Jimena Fernández De La Vega, 140 1ºH Gijón, ES 33203 |
| Contact | Pablo Boto |
| Correspondent | Vardhini Kirthivas Freyr Global Regulatory Solutions And Services Level 4 Building No. H-08, Phoenix SEZ Phase 2 Gachibowli, Hyderabad, IN 500081 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08437019546014 | K214049 | 000 |