# K221873: NeoGen PSR System

- Pathway: 510(k) (Special)
- Applicant: Energist Limited
- Decided: Jan 12, 2023 after 198 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K943450 (1995). 150 ancestors in all.
No later device cites it as a predicate yet.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132754: Neogen PSR System, Energist, Ltd. (2013) Summary page 5.
- K072394: Portrait Stand-Off, Rhytec Incorporated (2007) Summary page 11.

## Indications for use
When used with the 5mm nozzle the NeoGen PSR System is intended for treatment of the following dermatological conditions: • Treatment of wrinkles and rhytids • Superficial skin lesions • Actinic Keratosis • Viral Papillomata • Seborrheic Keratosis • Acne Scars When used with the 25mm nozzle, the NeoGen PSR System is intended for coagulation of tissue in dermatological procedures.

Source page: https://510kreport.com/device/K221873
Methodology: https://510kreport.com/methodology