# K011423: Inpulse Dental Laser

- Pathway: 510(k) (Traditional)
- Applicant: Incisive, LLC
- Decided: Aug 7, 2001 after 90 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
No predicates in its family tree.
138 later devices descend from it; 2 cite it directly.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K083616: Patholase Family of Pinpointe and Pinpointe  Footlaser ND: Yag Lasers (2009), 136 descendants of its own
- K083215: Incisive Family of Inpulse ND:Yag Lasers (2009), 136 descendants of its own
- K093545: Pinpointe Footlaser Model 6W, 30W, 100W (2010), 122 descendants of its own
- K103626: Cutera Genesisplus Laser System (2011), 121 descendants of its own
- K093547: Pinpointe Footlaser (2010), 115 descendants of its own

Source page: https://510kreport.com/device/K011423
Methodology: https://510kreport.com/methodology