510(k) · Cleared
ClearedAtoven
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Med USA, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 6, 2014 as substantially equivalent to K110364 (Dornier Medtech America, Inc., 2011) after a 176-day review. Its family tree reaches back 12 generations to 1992. 6 later devices descend from it.
- Decided
- Jun 6, 2014
- Review
- 176 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K910422 (1992). 260 ancestors in all, the oldest K771218 (1978). 6 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations between
- 3 generations backK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- 2 generations backK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- 1 generation backK110364 Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc. · 2011
- This deviceK133774 AtovenBio-Med USA, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK160952 Alma Diode Tabletop LaserAlma, Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK241791 Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D…Gigaalaser Company, Ltd. · 2025
- Descendant · 2 generations on · 1 of its ownK234004 Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK262426 Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK251699 The Botticelli (Model: Athena)Bellamia Technologies, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 10 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 9 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 8 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 7 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 6 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 5 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 4 generations backK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- 3 generations backK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- 2 generations backK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- 1 generation backK110364 Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc. · 2011
- This deviceK133774 AtovenBio-Med USA, Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K160952Alma Diode Tabletop LaserAlma, Ltd. · 2016 · cites it directly5descendants
- K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd. · 2025 · 2 generations on1descendant
- K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd. · 2025 · 2 generations on1descendant
- K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −11 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −9 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −8 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −7 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −6 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −5 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −4 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| −3 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| −2 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| −1 | K110364 | Dornier Medilas D Litebeam+ 1470 | Dornier Medtech America, Inc. | 2011 | — |
| 0 (this device) | K133774 | Atoven | Bio-Med USA, Inc. | 2014 | — |
| +1 | K160952 | Alma Diode Tabletop Laser | Alma, Ltd. | 2016 | — |
| +2 | K241791 | Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS… | Gigaalaser Company, Ltd. | 2025 | — |
| +2 | K234004 | Medical diode laser systems (CHARISMA, REGAL) | Reveal Lasers, Ltd. | 2025 | — |
| +3 | K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) | Wuhan Pioon Technology Co., Ltd. | 2026 | — |
| +3 | K251699 | The Botticelli (Model: Athena) | Bellamia Technologies, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 11 | 0 |
| 1994 | 15 | 0 |
| 1995 | 15 | 0 |
| 1996 | 20 | 0 |
| 1997 | 24 | 0 |
| 1998 | 20 | 0 |
| 1999 | 16 | 0 |
| 2000 | 21 | 0 |
| 2001 | 24 | 0 |
| 2002 | 27 | 0 |
| 2003 | 20 | 0 |
| 2004 | 9 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K110364 | Dornier Medilas D Litebeam+ 1470Summary page 1…Regulation : 880.4810 Class 11 Product Code : GEX 4. Legally marketed Predicate Device K1 10364 LiteBeam+1470 Dornier Med-fech 5. Intended use ATOVEN is a diode laser system designed to d… | 2011 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160952 | Alma Diode Tabletop Laser | 2016 | 5 |
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 22 years and passes through 10 companies; a new generation was cleared every 1.7 years on median.
- 12 of the 260 ancestors have a recall of any class.
- Of its descendants, K160952 (Alma, Ltd., 2016) has gone furthest, with 5 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
ATOVEN is a diode laser system designed to delivery of laser light to soft tissue during general surgery procedures. This
device intended for treatment of reflux of the saphenous veins of thigh associated with varicose veins and varicosities.
Non-Contact mode
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133774: Atoven.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133774
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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