510(k) · Cleared
ClearedEmvera Diolux
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emvera Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 14, 2012 as substantially equivalent to K102716 (Alma Lasers, Inc., 2010) after a 57-day review. Its family tree reaches back 10 generations to 1992. 3 later devices descend from it.
- Decided
- Dec 14, 2012
- Review
- 57 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K910422 (1992). 58 ancestors in all, the oldest K871179 (1987). 3 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- 2 generations backK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
- 1 generation backK102716 Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010
- This deviceK123257 Emvera DioluxEmvera Technologies, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK152898 Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK191611 Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd. · 2019 · Recalled
- Descendant · cites it directly · 0 of its ownK141986 Elux 810 LaserEquipmed North America, Inc. · 2015
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 5 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 4 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 3 generations backK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- 2 generations backK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
- 1 generation backK102716 Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010
- This deviceK123257 Emvera DioluxEmvera Technologies, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See all- K152898Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd. · 2016 · cites it directly1descendant
- K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd. · 2019 · 2 generations on0descendants
- K141986Elux 810 LaserEquipmed North America, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −5 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −4 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −3 | K042165 | Cutera Tabletop Aesthetic Product | Cutera, Inc. | 2004 | 1 |
| −2 | K080318 | Alma Laser Nir Module | Alma Lasers, Ltd. | 2008 | — |
| −1 | K102716 | Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms | Alma Lasers, Inc. | 2010 | — |
| 0 (this device) | K123257 | Emvera Diolux | Emvera Technologies, Inc. | 2012 | — |
| +1 | K152898 | Diode Laser Therapy Systems | Beijing Sincoheren Science and Tech. Development Co., Ltd. | 2016 | — |
| +2 | K191611 | Diode Laser Therapy Systems | Wingderm Electro-Optics, Ltd. | 2019 | 1 |
| +1 | K141986 | Elux 810 Laser | Equipmed North America, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 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? (1)
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 |
|---|---|---|---|
| * | K102716 | Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsSummary page 1…cal Devices Predicate Device: Manufacturer Trade Name 510 k)Numnber Alma Lasers, Inc. Soprano XL K102716 Device Description This laser operation equipment is a diode laser of SO8nm of pulsed diode laser. This equipment is composed o… | 2010 |
What descends from it? (3)
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 20 years and passes through 9 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 58 ancestors have a recall of any class.
- Of its descendants, K152898 (Beijing Sincoheren Science and Tech. Development Co., Ltd., 2016) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K102716.
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 Emvera Diolux is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Hair removal by laser or IPL sources can cause increase hair growth in some individuals. Based upon currently available data, the highest risk groups for this response are females of Mediterranean, Middle Eastern, and South Asian heritage treated on the face and neck.
Caution: Federal (USA) law restricts this device for use by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123257 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123257: Emvera Diolux.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123257
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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