# K122122: Regen Spray Applicator,

- Pathway: 510(k) (Traditional)
- Applicant: Regen Lab SA
- Decided: Nov 9, 2012 after 115 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K012868 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012868: Micromedics Fibrijet Aerosol Applicator, Micromedics, Inc. (2001)

## Indications for use
Regen Spray Applicator (models R-A/NAC1 & R-A/NAC3) is designed for use in applying two non-homogeneous fluids or liquids to a treatment site as deemed necessary by the clinical use requirements. Regen Spray Applicator (models R-A/NAC I & R-A/NAC3) is for single use only.

Source page: https://510kreport.com/device/K122122
Methodology: https://510kreport.com/methodology