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 |