The following data is part of a premarket notification filed by Energist, Ltd. with the FDA for Energist Ultra Vpl Intense Pulse Light System.
| Device ID | K060216 |
| 510k Number | K060216 |
| Device Name: | ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ENERGIST, LTD. 2 CLOS LLYN CWM ENTERPRISE PARK Swansea, GB Sa6 8qy |
| Contact | Peter Smith |
| Correspondent | Peter Smith 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 | 2006-01-27 |
| Decision Date | 2006-03-16 |
| Summary: | summary |