510(k) · Cleared
ClearedD-Storm 810NM, D-Storm 980NM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Instruments · GEX Powered Laser Surgical Instrument
Cleared on Mar 23, 2010 as substantially equivalent to K073411 (Light Instruments, 2008) and 2 other predicates after a 174-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Mar 23, 2010
- Review
- 174 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K931783 (1993). 68 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 9 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 5 generations between
- 3 generations backK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- 2 generations backK061966 Litetouch Dental Laser SystemLight Instrument, Ltd. · 2006
- 1 generation backK073411 LiteduoLight Instruments · 2008
- This deviceK093048 D-Storm 810NM, D-Storm 980NMLight Instruments · 2010
Show all 9 generations
- Root · 9 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 8 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 7 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 6 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 5 generations backK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- 4 generations backK032117 Stryker Total Performance (TPS) SystemStryker Instruments · 2003
- 3 generations backK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- 2 generations backK061966 Litetouch Dental Laser SystemLight Instrument, Ltd. · 2006
- 1 generation backK073411 LiteduoLight Instruments · 2008
- This deviceK093048 D-Storm 810NM, D-Storm 980NMLight Instruments · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −8 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −7 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −6 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −5 | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| −4 | K032117 | Stryker Total Performance (TPS) System | Stryker Instruments | 2003 | — |
| −3 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| −2 | K061966 | Litetouch Dental Laser System | Light Instrument, Ltd. | 2006 | — |
| −1 | K073411 | Liteduo | Light Instruments | 2008 | — |
| 0 (this device) | K093048 | D-Storm 810NM, D-Storm 980NM | Light Instruments | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 8 | 0 |
| 1999 | 7 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K073411 | LiteduoSummary page 2…cate devices is claimed: Device Name Manufacture 510k No 'Clearance Date LITEDUO Light Instruments Ltd K(073411 May 13, 2008 DioDent Micro Hya Conbio, Inc K(063384 March 16, 2007 FOTONA Xrn… | 2008 |
| * | K063384 | Diodent Micro Dental Laser System, Models 810 and 980Summary page 2…510k No 'Clearance Date LITEDUO Light Instruments Ltd K(073411 May 13, 2008 DioDent Micro Hya Conbio, Inc K(063384 March 16, 2007 FOTONA Xrn FOTONA K(083034 Feb 04, 2009 Performance Stan… | 2007 |
| * | K083034 | Fotona XD-2 Diode Laser System, Model MD01-2FSummary page 2…3411 May 13, 2008 DioDent Micro Hya Conbio, Inc K(063384 March 16, 2007 FOTONA Xrn FOTONA K(083034 Feb 04, 2009 Performance Standards B-STORM Diode Laser System complies with U.S. Federal Performance… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 68 ancestors have a recall of any class.
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 D-Storm system is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry. The D-Storm diode laser system is indicated for: * Incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry • Light activation of bleaching materials for teeth whitening The D-Storm specific indications include the following: Marginal and interdental gingiva…
Read the full statement (156 words)
The D-Storm system is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry.
The D-Storm diode laser system is indicated for:
* Incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry
• Light activation of bleaching materials for teeth whitening
The D-Storm specific indications include the following:
Marginal and interdental gingiva and epithelia] lining of free gingiva, frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gignigivioplasty, gingival troughing crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelia] lining, incision and draining of abscesses, tissue retraction, for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphtous ulcers, leukoplakia, sulcular debridemnent (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy as adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093048 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093048: D-Storm 810NM, D-Storm 980NM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093048
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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