510(k) · Cleared
ClearedPulsemaster 1000 ST Dental Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Dental Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 19, 1997 as substantially equivalent to K922901 (Buckman Co., Inc., 1992) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1992. 318 later devices descend from it.
- Decided
- Sep 19, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922901 (1992). 2 ancestors in all. 318 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- This deviceK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- Descendant · cites it directly · 280 of its ownK991994 TwilightBiolase Technology, Inc. · 1999
- Descendant · 2 generations on · 246 of its ownK012511 Waterlase MillenniumBiolase Technology, Inc. · 2002
- Descendant · 3 generations on · 240 of its ownK021508 Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002
- Descendant · 4 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- Descendant · 5 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
Showing 5 of 318 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 318 · See all- K991994TwilightBiolase Technology, Inc. · 1999 · cites it directly280descendants
- K012511Waterlase MillenniumBiolase Technology, Inc. · 2002 · 2 generations on246descendants
- K021508Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002 · 3 generations on240descendants
- K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 4 generations on226descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 5 generations on221descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| 0 (this device) | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| +1 | K991994 | Twilight | Biolase Technology, Inc. | 1999 | — |
| +2 | K012511 | Waterlase Millennium | Biolase Technology, Inc. | 2002 | — |
| +3 | K021508 | Opusduo EC Dental Laser System | Opusdent, Ltd. | 2002 | — |
| +4 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| +5 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 7 | 0 |
| 2008 | 18 | 0 |
| 2009 | 8 | 0 |
| 2010 | 15 | 0 |
| 2011 | 11 | 0 |
| 2012 | 8 | 0 |
| 2013 | 14 | 0 |
| 2014 | 14 | 0 |
| 2015 | 13 | 0 |
| 2016 | 11 | 0 |
| 2017 | 12 | 0 |
| 2018 | 15 | 0 |
| 2019 | 11 | 0 |
| 2020 | 17 | 0 |
| 2021 | 12 | 0 |
| 2022 | 27 | 0 |
| 2023 | 15 | 0 |
| 2024 | 26 | 0 |
| 2025 | 32 | 0 |
| 2026 | 20 | 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 |
|---|---|---|---|
| * | K922901 | Incisor I Pulsed ND:Yag Laser SystemSummary page 1…ication Name: Laser Surgical Instrument Classification Status: Class 1 3. PREDICATE DEVICES » PulseMaster® 1000 Dental Laser System American Dental Technologies, Inc. K922901 . Aurora™ Diode Laser System Premier Laser Systems, Inc. K954316 4. DEVICE DESCRIPTION AND INTENDED USE The PulseMaster® 1000… | 1992 |
| * | K954316 | Aurora Surgical Diode Laser System W/AccessoriesSummary page 1…ass 1 3. PREDICATE DEVICES » PulseMaster® 1000 Dental Laser System American Dental Technologies, Inc. K922901 . Aurora™ Diode Laser System Premier Laser Systems, Inc. K954316 4. DEVICE DESCRIPTION AND INTENDED USE The PulseMaster® 1000 ST Dental Laser System is a portable diode laser system intended f… | 1995 |
What descends from it? (318)
See all 3182 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PulseMaster® 1000 ST Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is indicated for use in the following procedures: lesion (tumor) removal biopsies fibroma removal frenectomies and frenotomies gingivoplasties gingivectomies leukoplakia operculectomies oral…
Read the full statement (91 words)
The PulseMaster® 1000 ST Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is indicated for use in the following procedures:
lesion (tumor) removal
biopsies
fibroma removal
frenectomies and frenotomies
gingivoplasties
gingivectomies
leukoplakia
operculectomies
oral papillectomies
aphthous ulcers
sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972325: Pulsemaster 1000 ST Dental Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972325
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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