The following data is part of a premarket notification filed by High Technology Products Slu with the FDA for Primelase Excellence.
| Device ID | K201594 |
| 510k Number | K201594 |
| Device Name: | Primelase Excellence |
| Classification | Powered Laser Surgical Instrument |
| Applicant | High Technology Products SLU Pasaje Masoliver 24 Barcelona, ES 08005 |
| Contact | Sergi Lozano |
| Correspondent | Vardhini Kirthivas Freyr Global Regulatory Solutions & 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 | 2020-06-12 |
| Decision Date | 2020-12-17 |