# K130028: Resurfx 1565NM Laser Module

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Ltd.
- Decided: Sep 3, 2013 after 243 days
- Product code: ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output)
- 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: 17 generations back to K910422 (1992). 252 ancestors in all.
41 later devices descend from it; 4 cite it directly.
0 of 294 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091420: Fraxel RE: Store Laser System, Model SR1500, Solta Medical, Inc. (2009) Summary page 2.
- K110907: Palomar Icon (TM) Aesthetic System, Palomar Medical Technologies, Inc. (2011) Summary page 2.
- (no number) Palomar Lux1540: named in the summary without a submission number

## Most influential descendants
- K142860: Lumenis M22 System (2015), 38 descendants of its own
- K170060: M22 and ResurFx Systems (2017), 24 descendants of its own
- K193500: Stellar M22 for Intense Pulsed Light (IPL) and Laser System (2020), 12 descendants of its own
- K203441: The Alma Hybrid Laser System (2021), 5 descendants of its own
- K202884: SR-1 Skin Treatment System (2021), 4 descendants of its own

## Indications for use
The 1565nm ResurFX laser module is indicated for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue

Source page: https://510kreport.com/device/K130028
Methodology: https://510kreport.com/methodology