Energist Limited
Swansea Swansea, GB
ENERGIST LIMITED appears in FDA device records in Swansea Swansea, GB. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Energist Limited between 2006 and 2023. The busiest year on record is 2006, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2009 | 1 |
| 2013 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221873 | NeoGen PSR System | GEI | Substantially Equivalent | |
| K132754 | NEOGEN PSR SYSTEM | GEI | Substantially Equivalent | |
| K082825 | ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM | GEX | Substantially Equivalent | |
| K060216 | ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007353760 | 3007353760 | ENERGIST LIMITED | 2 Park Pavilions, Clos Llyn Cwm, Swansea SA6 8QY GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain