# K090639: EXELO2, Model 4010

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Derma GmbH
- Decided: Oct 29, 2009 after 233 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: 13 generations back to K910422 (1992). 150 ancestors in all.
No later device cites it as a predicate yet.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080915: Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories, Reliant Technologies, Inc. (2008) Summary page 1.

## Indications for use
The EXELO2 with the fractional scanning unit is indicated for ablative skin resurfacing in people with skin types 1, 2 or 3 based on Fitzpatrick skin type scale.

Source page: https://510kreport.com/device/K090639
Methodology: https://510kreport.com/methodology