510(k) · Cleared
ClearedLasersystem Beautystar 532
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asclepion-Meditec AG · GEX Powered Laser Surgical Instrument
Cleared on Sep 13, 2002 as substantially equivalent to K990174 (Fisma, Inc., 1999) and 4 other predicates after an 88-day review. Its family tree reaches back 4 generations to 1994. 24 later devices descend from it.
- Decided
- Sep 13, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K933880 (1994). 14 ancestors in all, the oldest K883541 (1988). 24 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 3 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 2 generations backK964074 Diolite 532Iriderm Div. · 1997
- 1 generation backK020071 Viridis Derma LaserQuantel Medical · 2002
- This deviceK021975 Lasersystem Beautystar 532Asclepion-Meditec AG · 2002
- Descendant · cites it directly · 23 of its ownK042496 Adept Ultralite 532 LaserAdept Medical Concepts · 2004
- Descendant · 2 generations on · 22 of its ownK063396 Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L. · 2007
- Descendant · 3 generations on · 20 of its ownK100143 Pilot Diode Laser, Model 002-00139CAO Group, Inc. · 2010
- Descendant · 4 generations on · 9 of its ownK123443 Precise SHP Diode LaserCAO Group, Inc. · 2013
- Descendant · 3 generations on · 7 of its ownK102036 Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K042496Adept Ultralite 532 LaserAdept Medical Concepts · 2004 · cites it directly23descendants
- K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L. · 2007 · 2 generations on22descendants
- K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc. · 2010 · 3 generations on20descendants
- K123443Precise SHP Diode LaserCAO Group, Inc. · 2013 · 4 generations on9descendants
- K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −3 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −2 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −1 | K020071 | Viridis Derma Laser | Quantel Medical | 2002 | — |
| 0 (this device) | K021975 | Lasersystem Beautystar 532 | Asclepion-Meditec AG | 2002 | — |
| +1 | K042496 | Adept Ultralite 532 Laser | Adept Medical Concepts | 2004 | — |
| +2 | K063396 | Velure Family of Diode Lasers and Delivery Device Accessories | Lasering S.R.L. | 2007 | — |
| +3 | K100143 | Pilot Diode Laser, Model 002-00139 | CAO Group, Inc. | 2010 | — |
| +4 | K123443 | Precise SHP Diode Laser | CAO Group, Inc. | 2013 | — |
| +3 | K102036 | Doctor Surgery Diode Lasers Family | Lambda S.P.A. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990174 | Atlas-Elite,Model E-80,Corium 200,Corium 400, Model E-90, Elite, Model E-80-II, Elite…Summary page 1…very similar to those of legally marketed lasers such as the HGM Atlas-Elite, Model E-80, Corium 200/400 (K990174), Laserscope File 510K SUMMARY BeautyStar DOC Page 1 of 2 === Pa… | 1999 |
| * | K951034 | Aura Laser SystemSummary page 2…990174), Laserscope File 510K SUMMARY BeautyStar DOC Page 1 of 2 Aura (K951034), Medart Corp. MedArt 470(KOlU885), lridex Corp. DioLite 532 (K964074, Ceramoptec Ceralase… | 1995 |
| Kept off the family tree | K010885 | FDA’s K010885 is Uni-Laser 470 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K964074 | Diolite 532Summary page 2…Page 1 of 2 Aura (K951034), Medart Corp. MedArt 470(KOlU885), lridex Corp. DioLite 532 (K964074, Ceramoptec Ceralase G I 5(K002296) and Quantel Medical Viridis Derm (K020071) Performance data: None. The s… | 1997 |
| * | K002296 | Ceralas G15 532NM Frequency Doubled ND:Yag Laser, Model G1-G15Summary page 2…= Aura (K951034), Medart Corp. MedArt 470(KOlU885), lridex Corp. DioLite 532 (K964074, Ceramoptec Ceralase G I 5(K002296) and Quantel Medical Viridis Derm (K020071) Performance data: None. The specifications and intended uses of the laser system… | 2000 |
| * | K020071 | Viridis Derma LaserSummary page 2…Corp. MedArt 470(KOlU885), lridex Corp. DioLite 532 (K964074, Ceramoptec Ceralase G I 5(K002296) and Quantel Medical Viridis Derm (K020071) Performance data: None. The specifications and intended uses of the laser system BeautyStar 532 are the same… | 2002 |
| * | — | HGM Atlas-Elite, Model E-80 Named without a submission number |
What descends from it? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042496 | Adept Ultralite 532 Laser | 2004 | 23 |
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 8 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K042496 (Adept Medical Concepts, 2004) has gone furthest, with 23 descendants of its own.
- 2 other devices also cite its predicate K990174.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 BeautyStar 532 is intended for Vaporization and Photocoagulation of vascular and pigmented lesions in soft tissue.
The laser system BeautyStar is restricted to sale to or use by licensed professionals in the United States.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021975: Lasersystem Beautystar 532.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021975
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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