510(k) · Cleared
ClearedMira Lasers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mira Lasers, LLC · GEX Powered Laser Surgical Instrument
Cleared on Jan 15, 2013 as substantially equivalent to K113212 (China Daheng Group, Inc., 2011) and 1 other predicate after a 110-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Jan 15, 2013
- Review
- 110 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K922901 (1992). 33 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 5 generations between
- 3 generations backK081214 Styla Microlaser and StylaorthoZap Lasers, LLC · 2008
- 2 generations backK093852 Ezlase 3 Laser SystemBiolase Technology, Inc. · 2010
- 1 generation backK113212 Dental Laser Therapy SystemChina Daheng Group, Inc. · 2011
- This deviceK123004 Mira LasersMira Lasers, LLC · 2013
Show all 9 generations
- Root · 9 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 8 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 7 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- 6 generations backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
- 5 generations backK053161 SirolaserSirona Dental Systems GmbH · 2006
- 4 generations backK062258 Genesis Diode LaserIvoclar Vivadent, Inc. · 2007
- 3 generations backK081214 Styla Microlaser and StylaorthoZap Lasers, LLC · 2008
- 2 generations backK093852 Ezlase 3 Laser SystemBiolase Technology, Inc. · 2010
- 1 generation backK113212 Dental Laser Therapy SystemChina Daheng Group, Inc. · 2011
- This deviceK123004 Mira LasersMira Lasers, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −8 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −7 | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| −6 | K991891 | Ceralas Diode Laser System, Model Ceralas D15 | Ceram Optec, Inc. | 1999 | — |
| −5 | K053161 | Sirolaser | Sirona Dental Systems GmbH | 2006 | — |
| −4 | K062258 | Genesis Diode Laser | Ivoclar Vivadent, Inc. | 2007 | — |
| −3 | K081214 | Styla Microlaser and Stylaortho | Zap Lasers, LLC | 2008 | — |
| −2 | K093852 | Ezlase 3 Laser System | Biolase Technology, Inc. | 2010 | — |
| −1 | K113212 | Dental Laser Therapy System | China Daheng Group, Inc. | 2011 | — |
| 0 (this device) | K123004 | Mira Lasers | Mira Lasers, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K113212 | Dental Laser Therapy SystemSummary page 2…hitening/bleaching of teeth *Light activation for bleaching materials ffix teeth whitening 5. Predicate Device Identification 5 10(k) Number: K 113212 Product Name: Dental Laser Therapy System Manufacturer: China Daheng Group, Inc. 5 10(k) Number. K083 142 P… | 2011 |
| * | K083142 | Picasso Laser SystemSummary page 2…e Device Identification 5 10(k) Number: K 113212 Product Name: Dental Laser Therapy System Manufacturer: China Daheng Group, Inc. 5 10(k) Number. K083 142 Predicate Device Name: Picasso" Manufacturer: AND LASERS Th ', LLC 6. Device Description The proposed device… | 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 21 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 33 ancestors has 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. 2013, 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 MIRA LASERS is indicated for incision, excision, hemostasis, coagulation and vaporization of soft tissue including the following indications: - Excision and Incision Biopsies - Hemostatic assistance - Treatment of Apthous Ulcers - Frenectomy - Frenotomy - Gingival Incision and Excision - Gingivectomy - Gingivoplasty - Incising and Draining of Abscesses - Operculectomy - Oral Papillectomy - Removal of Fibromas - Soft Tissue Crown Lengthening -…
Read the full statement (100 words)
The MIRA LASERS is indicated for incision, excision, hemostasis, coagulation and vaporization of soft tissue including the following indications:
- Excision and Incision Biopsies
- Hemostatic assistance
- Treatment of Apthous Ulcers
- Frenectomy
- Frenotomy
- Gingival Incision and Excision
- Gingivectomy
- Gingivoplasty
- Incising and Draining of Abscesses
- Operculectomy
- Oral Papillectomy
- Removal of Fibromas
- Soft Tissue Crown Lengthening
- Sulcular Debridement (removal of diseased or inflamned soft tissutein the periodontal pocket)
- Tissue retraction for Impression
- Vestibuloplasty
- Laser assisted whitening/bleaching of teeth
- Light activation for bleaching materials for teeth whitening
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123004: Mira Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123004
Report an extraction error
Are you the manufacturer?
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