# K062589: Serenity PSF (Pneumatic Skin Flattening) System

- Pathway: 510(k) (Traditional)
- Applicant: Inolase 2002, Ltd.
- Decided: Nov 30, 2006 after 90 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K910422 (1992). 28 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041554: Aip Intense Pulsed Light System, Aesthera Corporation (2005) Summary page 1.

## Most influential descendants
- K071469: Inolase Serenity PSF ( Pneumatic Skin Flattening) System (2007), 1 descendant of its own
- K071943: Serenity Pro PSF System (2007), 1 descendant of its own
- K072925: Candela-Inolase Serenity Pro PSF System (2008), 0 descendants of its own

## Indications for use
The Serenity PSF T" (Pneumatic Skin Flattening) System is an accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration of the treatment beam through it.

Source page: https://510kreport.com/device/K062589
Methodology: https://510kreport.com/methodology