510(k) · Cleared
ClearedAdept Ultralite 532 Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adept Medical Concepts · GEX Powered Laser Surgical Instrument
Cleared on Nov 2, 2004 as substantially equivalent to K021975 (Asclepion-Meditec AG, 2002) after a 49-day review. Its family tree reaches back 5 generations to 1994. 23 later devices descend from it.
- Decided
- Nov 2, 2004
- Review
- 49 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K933880 (1994). 15 ancestors in all, the oldest K883541 (1988). 23 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 4 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 3 generations backK964074 Diolite 532Iriderm Div. · 1997
- 2 generations backK020071 Viridis Derma LaserQuantel Medical · 2002
- 1 generation backK021975 Lasersystem Beautystar 532Asclepion-Meditec AG · 2002
- This deviceK042496 Adept Ultralite 532 LaserAdept Medical Concepts · 2004
- Descendant · cites it directly · 22 of its ownK063396 Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L. · 2007
- Descendant · 2 generations on · 20 of its ownK100143 Pilot Diode Laser, Model 002-00139CAO Group, Inc. · 2010
- Descendant · 3 generations on · 9 of its ownK123443 Precise SHP Diode LaserCAO Group, Inc. · 2013
- Descendant · 2 generations on · 7 of its ownK102036 Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010
- Descendant · 3 generations on · 6 of its ownK122567 Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L. · 2007 · cites it directly22descendants
- K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc. · 2010 · 2 generations on20descendants
- K123443Precise SHP Diode LaserCAO Group, Inc. · 2013 · 3 generations on9descendants
- K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010 · 2 generations on7descendants
- K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −4 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −3 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −2 | K020071 | Viridis Derma Laser | Quantel Medical | 2002 | — |
| −1 | K021975 | Lasersystem Beautystar 532 | Asclepion-Meditec AG | 2002 | — |
| 0 (this device) | K042496 | Adept Ultralite 532 Laser | Adept Medical Concepts | 2004 | — |
| +1 | K063396 | Velure Family of Diode Lasers and Delivery Device Accessories | Lasering S.R.L. | 2007 | — |
| +2 | K100143 | Pilot Diode Laser, Model 002-00139 | CAO Group, Inc. | 2010 | — |
| +3 | K123443 | Precise SHP Diode Laser | CAO Group, Inc. | 2013 | — |
| +2 | K102036 | Doctor Surgery Diode Lasers Family | Lambda S.P.A. | 2010 | — |
| +3 | K122567 | Joule 810/940/980 Multi-Platform System | Sciton, Inc | 2013 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K021975 | Lasersystem Beautystar 532Summary page 1…Imedical device; (21 CFR 878.4810). Product Code: GEX Panel: 79 Predicate device: The Laser System BeautyStar 532 Laser (K021975). Device description: The Adept UltraLite 532 Laser is a diode laser which emits coherent light at 532 nm.… | 2002 |
| * | — | DioLite 532 laser Named without a submission number |
What descends from it? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063396 | Velure Family of Diode Lasers and Delivery Device Accessories | 2007 | 22 |
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 10 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K063396 (Lasering S.R.L., 2007) has gone furthest, with 22 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.
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 ADEPT ULTRALITE 532 LASER is intended for vaporization and photocoagulation of vascular and pigmented lesions in soft tissue.
Examples include:
Telangiectasia
Spider Naevi
Angioma
Hemangioma
Leg veins (small, superficial - see above)
Epidermal Naevi
Lentigines (solar and senile)
Verrucae Vulgares (Warts)
Cherry Angioma
Port Wine Stain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042496: Adept Ultralite 532 Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042496
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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