# K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Jul 11, 2014 after 308 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: 19 generations back to K943450 (1995). 512 ancestors in all.
70 later devices descend from it; 4 cite it directly.
0 of 583 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101306: SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models M021-4AF/3, M002-2A, Fotona D.D. (2011) Summary page 1.
- K101916: Joule Multi-Platform System, Sciton, Inc (2011) Summary page 1.
- K081541: Dermablate Effect, Asclepion Laser Technologies GmbH (2009) Summary page 1.

## Most influential descendants
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own
- K153671: Family of CoolGlide Aesthetic Lasers (2016), 32 descendants of its own
- K170626: Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece (2017), 24 descendants of its own
- K172193: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules (2018), 22 descendants of its own
- K182088: XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro (2018), 20 descendants of its own

## Indications for use
The Fotona F-22 Handpiece is intended for: In fractionated mode: Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece; In non-fractionated mode: General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation is necessary; The Fotona FS-01 Handpiece is intended for: Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece.

Source page: https://510kreport.com/device/K132806
Methodology: https://510kreport.com/methodology