510(k) · Cleared
ClearedDermastar ER:Yag Laser System
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 Mar 8, 2002 as substantially equivalent to K980361 (Aesculap-Meditec North America, 1998) after an 88-day review. Its family tree reaches back 3 generations to 1996. 18 later devices descend from it.
- Decided
- Mar 8, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K954013 (1996). 4 ancestors in all. 18 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK954013 Trilase 2940 Erbium LaserSchwartz Electro-Optics, Inc. · 1996
- 2 generations backK961748 Medlite/Erbium Laser SystemContinuum Biomedical, Inc. · 1996
- 1 generation backK980361 Dermablate ER: Yag Laser SystemAesculap-Meditec North America · 1998
- This deviceK014057 Dermastar ER:Yag Laser SystemAsclepion-Meditec AG · 2002
- Descendant · cites it directly · 13 of its ownK032599 Medical Laser Technologies, LLC MTL Erbium:Yag Laser SystemMedical Laser Technologies, LLC · 2003
- Descendant · 2 generations on · 2 of its ownK110897 Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC · 2011
- Descendant · 2 generations on · 2 of its ownK110502 Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC · 2011
- Descendant · 2 generations on · 2 of its ownK110304 Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC · 2011
- Descendant · 2 generations on · 2 of its ownK063867 Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2007
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K032599Medical Laser Technologies, LLC MTL Erbium:Yag Laser SystemMedical Laser Technologies, LLC · 2003 · cites it directly13descendants
- K110897Cortex CO2 / ER:Yag Laser SystemSandstone Medical Technologies, LLC · 2011 · 2 generations on2descendants
- K110502Triplex ER. Yag / ND: Yag SystemSandstone Medical Technologies, LLC · 2011 · 2 generations on2descendants
- K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC · 2011 · 2 generations on2descendants
- K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2007 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954013 | Trilase 2940 Erbium Laser | Schwartz Electro-Optics, Inc. | 1996 | — |
| −2 | K961748 | Medlite/Erbium Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −1 | K980361 | Dermablate ER: Yag Laser System | Aesculap-Meditec North America | 1998 | — |
| 0 (this device) | K014057 | Dermastar ER:Yag Laser System | Asclepion-Meditec AG | 2002 | — |
| +1 | K032599 | Medical Laser Technologies, LLC MTL Erbium:Yag Laser System | Medical Laser Technologies, LLC | 2003 | — |
| +2 | K110897 | Cortex CO2 / ER:Yag Laser System | Sandstone Medical Technologies, LLC | 2011 | — |
| +2 | K110502 | Triplex ER. Yag / ND: Yag System | Sandstone Medical Technologies, LLC | 2011 | — |
| +2 | K110304 | Apex ER. Yag / Ipl System | Sandstone Medical Technologies, LLC | 2011 | — |
| +2 | K063867 | Cutera ER:Ysgg Laser Handpiece | Cutera, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980361 | Dermablate ER: Yag Laser SystemSummary page 2…Page 68 of 68 Ko1§0S7 The specifications of the DermaStar are the same as or very similar to those of legally marketed lasers such as Dermablate Er: YAG Laser System (K980361) and MCL 29 Dermablate Er: YAG Laser System (KS64128) None. The specifications and intended uses of the DermaStarEr:YAG laser sy… | 1998 |
| Kept off the family tree | K964128 | FDA’s K964128 is MCL 29 Dermablate Erbium Laser System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1997 |
What descends from it? (18)
See all 184 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 6 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K032599 (Medical Laser Technologies, LLC, 2003) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K980361.
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 DermaStar is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes)
The laser system DermaStar is restricted to sale to or use by licensed professionals in the United States.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014057 · printed Nov 4, 2026
Cite this page
510(k) Report. “K014057: Dermastar ER:Yag Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014057
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026