# K113472: Precise SHP Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: CAO Group, Inc.
- Decided: Aug 30, 2012 after 282 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
Longest line of descent: 6 generations back to K922901 (1992). 20 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062258: Genesis Diode Laser, Ivoclar Vivadent, Inc. (2007) Summary page 1.
- K062619: Denlaser 800 Plus, CAO Group, Inc. (2006)

## Most influential descendants
- K123443: Precise SHP Diode Laser (2013), 9 descendants of its own
- K162114: Photon, Photon Plus (2016), 3 descendants of its own
- K200693: K2 Mobile (2020), 2 descendants of its own
- K181601: Precise SHP Diode Laser (2019), 1 descendant of its own
- K171986: Sterling Supreme Diode Laser (2017), 1 descendant of its own

## Indications for use
The Precise SHP Diode Laser is indicated for the removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on oral soft tissue for the specific dental and oral surgery procedures of gingivectomy, frenectomy, operculectomy, contouring, biopsy, troughing, ulcer care, abscess care, sulcular debridement, soft tissue curettage, and removal of inflamed edematous tissue.

Source page: https://510kreport.com/device/K113472
Methodology: https://510kreport.com/methodology