510(k) · Cleared
ClearedSapphire ST Portable Diode Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Den-Mat Holdings, LLC · GEX Powered Laser Surgical Instrument
Cleared on Dec 29, 2010 as substantially equivalent to K062258 (Ivoclar Vivadent, Inc., 2007) and 2 other predicates after a 14-day review. Its family tree reaches back 7 generations to 1992. 2 later devices descend from it.
- Decided
- Dec 29, 2010
- Review
- 14 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K922901 (1992). 25 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 6 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 5 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- 4 generations backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
- 3 generations backK053161 SirolaserSirona Dental Systems GmbH · 2006
- 2 generations backK062258 Genesis Diode LaserIvoclar Vivadent, Inc. · 2007
- 1 generation backK081214 Styla Microlaser and StylaorthoZap Lasers, LLC · 2008
- This deviceK103667 Sapphire ST Portable Diode LaserDen-Mat Holdings, LLC · 2010
- Descendant · cites it directly · 0 of its ownK161185 LUCERNA Dental LaserViax Dental Lab · 2016
- Descendant · cites it directly · 0 of its ownK141838 Sol Portable Diode Laser Unit (with Wireless Foot Control)Regulatory Technology Services, LLC · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −6 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −5 | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| −4 | K991891 | Ceralas Diode Laser System, Model Ceralas D15 | Ceram Optec, Inc. | 1999 | — |
| −3 | K053161 | Sirolaser | Sirona Dental Systems GmbH | 2006 | — |
| −2 | K062258 | Genesis Diode Laser | Ivoclar Vivadent, Inc. | 2007 | — |
| −1 | K081214 | Styla Microlaser and Stylaortho | Zap Lasers, LLC | 2008 | — |
| 0 (this device) | K103667 | Sapphire ST Portable Diode Laser | Den-Mat Holdings, LLC | 2010 | — |
| +1 | K161185 | LUCERNA Dental Laser | Viax Dental Lab | 2016 | — |
| +1 | K141838 | Sol Portable Diode Laser Unit (with Wireless Foot Control) | Regulatory Technology Services, LLC | 2014 | — |
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 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 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? (3)
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…Laser instrument, surgical Product Code: GEX Predicate Device(s): Ivoclar Vivadent, Inc. Odyssey Navigator Diode Laser (K062258); Zap Lasers, LLC Styla Micro Laser/StylaOrtho Laser (K08 1214); [voclar Vivadent, Inc. Odyssey 2.46… | 2007 |
| * | K081214 | Styla Microlaser and StylaorthoSummary page 1…oclar Vivadent, Inc. Odyssey Navigator Diode Laser (K062258); Zap Lasers, LLC Styla Micro Laser/StylaOrtho Laser (K08 1214); [voclar Vivadent, Inc. Odyssey 2.46 (K050453)) Rationale for Substantial Equivalence lBoth the su… | 2008 |
| * | K050453 | Odyssey 2.4G, Denlaser Elite, Model 002-00050Summary page 1…(K062258); Zap Lasers, LLC Styla Micro Laser/StylaOrtho Laser (K08 1214); [voclar Vivadent, Inc. Odyssey 2.46 (K050453)) Rationale for Substantial Equivalence lBoth the subject and predicate laser devices share similar intended uses and indicatio… | 2005 |
What descends from it? (2)
2 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?
- The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 25 ancestors has a recall of any class.
- Of its descendants, K161185 (Viax Dental Lab, 2016) has gone furthest, with 0 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. 2010, 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 Sapphire ST Portable Diode Laser is intended for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fiberoptic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; frenectomy; frenotomy; gingival incision and excision; gingivectomy; gingivoplasty…
Read the full statement (105 words)
The Sapphire ST Portable Diode Laser is intended for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fiberoptic delivery system. Indications include excision and incision biopsies; hemostatic assistance; treatment of apthous ulcers; frenectomy; frenotomy; gingival incision and excision; gingivectomy; gingivoplasty; incising and draining abscesses; operculectomy; oral papillectomy; removal of fibromas; soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; vestibuloplasty, and light activation of bleaching materials for teeth whitening, laser-assisted bleaching /whitening of teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103667: Sapphire ST Portable 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/K103667
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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