# K123443: Precise SHP Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: CAO Group, Inc.
- Decided: Aug 13, 2013 after 278 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: 17 generations back to K943450 (1995). 207 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 217 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113472: Precise SHP Diode Laser, CAO Group, Inc. (2012) Summary page 4.
- K100143: Pilot Diode Laser, Model 002-00139, CAO Group, Inc. (2010) Summary page 4.
- K082938: Ezlase, Biolase Technology, Inc. (2008) Summary page 4.

## Most influential descendants
- 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
- K261047: Dental Diode Laser Device (Laser-Pen) (2026), 0 descendants of its own

## Indications for use
The Precise SHP Diode Laser is indicated for dentistry and oral soft tissue procedures of: 1) The removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, frenectomy, gingivectomy, troughing, and removal of inflamed edematous tissue. 2) Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions; 3) Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.

Source page: https://510kreport.com/device/K123443
Methodology: https://510kreport.com/methodology