# K101510: Fractional Skin Resurfacing (FSR) Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Endymed Medical, Ltd.
- Decided: Feb 17, 2011 after 261 days
- Product code: OUH (Skin Resurfacing Rf Applicator)
- 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: 16 generations back to K943450 (1995). 253 ancestors in all.
64 later devices descend from it; 5 cite it directly.
0 of 318 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073572: Matrix RF Applicator, Syneron Medical, Ltd. (2008) Summary page 2.
- K083461: Imagine TC Skin Therapy System, Endymion Medical, Ltd. (2009) Summary page 2.

## Most influential descendants
- K130501: Intensif (2014), 57 descendants of its own
- K180189: InMode System with Fractora3D/3D-90 Applicators (2018), 38 descendants of its own
- K192545: Potenza (2020), 20 descendants of its own
- K192695: InMode System with the Morpheus8 (Fractora) Applicators (2019), 16 descendants of its own
- K200947: InMode System with the Morhpeus8 Applicators (2020), 15 descendants of its own

## Indications for use
The Fractional Skin Resurfacing (FSR) Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin

Source page: https://510kreport.com/device/K101510
Methodology: https://510kreport.com/methodology