510(k) · Cleared
ClearedPrecise SHP Diode Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CAO Group, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Aug 30, 2012 as substantially equivalent to K062258 (Ivoclar Vivadent, Inc., 2007) and 1 other predicate after a 282-day review. Its family tree reaches back 6 generations to 1992. 10 later devices descend from it.
- Decided
- Aug 30, 2012
- Review
- 282 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K922901 (1992). 20 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 5 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 4 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- 3 generations backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
- 2 generations backK053161 SirolaserSirona Dental Systems GmbH · 2006
- 1 generation backK062258 Genesis Diode LaserIvoclar Vivadent, Inc. · 2007
- This deviceK113472 Precise SHP Diode LaserCAO Group, Inc. · 2012
- Descendant · cites it directly · 9 of its ownK123443 Precise SHP Diode LaserCAO Group, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK162114 Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK200693 K2 MobileHulaser, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK181601 Precise SHP Diode LaserCAO Group, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK171986 Sterling Supreme Diode LaserCAO Group, Inc. · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K123443Precise SHP Diode LaserCAO Group, Inc. · 2013 · cites it directly9descendants
- K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 2016 · 2 generations on3descendants
- K200693K2 MobileHulaser, Inc. · 2020 · 3 generations on2descendants
- K181601Precise SHP Diode LaserCAO Group, Inc. · 2019 · 2 generations on1descendant
- K171986Sterling Supreme Diode LaserCAO Group, Inc. · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −5 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −4 | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| −3 | K991891 | Ceralas Diode Laser System, Model Ceralas D15 | Ceram Optec, Inc. | 1999 | — |
| −2 | K053161 | Sirolaser | Sirona Dental Systems GmbH | 2006 | — |
| −1 | K062258 | Genesis Diode Laser | Ivoclar Vivadent, Inc. | 2007 | — |
| 0 (this device) | K113472 | Precise SHP Diode Laser | CAO Group, Inc. | 2012 | — |
| +1 | K123443 | Precise SHP Diode Laser | CAO Group, Inc. | 2013 | — |
| +2 | K162114 | Photon, Photon Plus | Zolar Technology & Mfg Co., Inc. | 2016 | — |
| +3 | K200693 | K2 Mobile | Hulaser, Inc. | 2020 | — |
| +2 | K181601 | Precise SHP Diode Laser | CAO Group, Inc. | 2019 | — |
| +2 | K171986 | Sterling Supreme Diode Laser | CAO Group, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062258 | Genesis Diode LaserSummary page 1…wered Laser Surgical Instrument Legally Marketed Predicate Devices for Substantial Equivalence: Odyssey Navigator Diode Laser, manufactured by Ivoclar Vivadent, Inc. (K062258) DenLaser 800 Plus, manufactured by CAO Group. Inc. (KO62619) Rationale for Substantial Equivalence: The aforementioned device… | 2007 |
| * | K062619 | Denlaser 800 Plus | 2006 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123443 | Precise SHP Diode Laser | 2013 | 9 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K123443 (CAO Group, Inc., 2013) has gone furthest, with 9 descendants of its own.
- 9 other devices also cite its predicate K062258.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113472: Precise SHP Diode Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113472
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026