The following data is part of a premarket notification filed by Energist, Ltd. with the FDA for Energist Ultraplus Variable Pulsed Light (vpl) System.
| Device ID | K082825 |
| 510k Number | K082825 |
| Device Name: | ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ENERGIST, LTD. 2 CLOS LLYN CWM ENTERPRISE PARK Swansea, GB Sa6 8qy |
| Contact | Tim Major |
| Correspondent | Tim Major ENERGIST, LTD. 2 CLOS LLYN CWM ENTERPRISE PARK Swansea, GB Sa6 8qy |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-25 |
| Decision Date | 2009-02-06 |