# K071469: Inolase Serenity PSF ( Pneumatic Skin Flattening) System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Aug 15, 2007 after 78 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: 8 generations back to K910422 (1992). 51 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062589: Serenity PSF (Pneumatic Skin Flattening) System, Inolase 2002, Ltd. (2006) Summary page 2.
- K001589: Candela Dynamic Cooling Device, Candela Corp. (2000) Summary page 2.

## Most influential descendants
- K072925: Candela-Inolase Serenity Pro PSF System (2008), 0 descendants of its own

## Indications for use
The Candela - Inolase Serenity PSFTM (Pneumatic Skin Flattening) System is indicated for the following uses: 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. Reduction of pain during Laser or Intense Pulse Light System treatment.

Source page: https://510kreport.com/device/K071469
Methodology: https://510kreport.com/methodology