# K072925: Candela-Inolase Serenity Pro PSF System

- Pathway: 510(k) (Traditional)
- Applicant: Inolase, Ltd.
- Decided: Jan 10, 2008 after 87 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: 9 generations back to K910422 (1992). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071469: Inolase Serenity PSF ( Pneumatic Skin Flattening) System, Candela Corp. (2007) Summary page 2.
- K071943: Serenity Pro PSF System, Inolase 2002, Ltd. (2007) Summary page 1.
- K062589: Serenity PSF (Pneumatic Skin Flattening) System, Inolase 2002, Ltd. (2006) Summary page 1.

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

Source page: https://510kreport.com/device/K072925
Methodology: https://510kreport.com/methodology