510(k) · Cleared
ClearedMCL 31 Dermablate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asclepion Laser Technologies GmbH · GEX Powered Laser Surgical Instrument
Cleared on Jun 5, 2015 as substantially equivalent to K081541 (Asclepion Laser Technologies GmbH, 2009) and 1 other predicate after a 134-day review. Its family tree reaches back 12 generations to 1995. 7 later devices descend from it.
- Decided
- Jun 5, 2015
- Review
- 134 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K943450 (1995). 151 ancestors in all, the oldest K800617 (1980). 7 later devices descend from it, 5 citing it directly.
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations between
- 3 generations backK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
- 2 generations backK090126 Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona…Fotona D.D. · 2009
- 1 generation backK101306 SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP…Fotona D.D. · 2011
- This deviceK150140 MCL 31 DermablateAsclepion Laser Technologies GmbH · 2015
- Descendant · cites it directly · 3 of its ownK210634 MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH · 2022
- Descendant · cites it directly · 2 of its ownK153229 SuperbiumBios S.R.L. · 2016
- Descendant · cites it directly · 0 of its ownK252561 BTL-754FFBTL Industries, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241600 DermablateAsclepion Laser Technologies GmbH · 2024
- Descendant · 2 generations on · 0 of its ownK213761 Joule diVa SystemSciton, Inc · 2022
Show all 12 generations
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 6 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 5 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- 4 generations backK041957 Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · Recalled
- 3 generations backK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
- 2 generations backK090126 Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona…Fotona D.D. · 2009
- 1 generation backK101306 SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP…Fotona D.D. · 2011
- This deviceK150140 MCL 31 DermablateAsclepion Laser Technologies GmbH · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH · 2022 · cites it directly3descendants
- K153229SuperbiumBios S.R.L. · 2016 · cites it directly2descendants
- K252561BTL-754FFBTL Industries, Inc. · 2026 · cites it directly0descendants
- K241600DermablateAsclepion Laser Technologies GmbH · 2024 · 2 generations on0descendants
- K213761Joule diVa SystemSciton, Inc · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −11 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −6 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −5 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| −4 | K041957 | Evlt Kit and the D15PLUS and D30PLUS Diode Lasers | Diomed, Inc. | 2004 | 1 |
| −3 | K051996 | Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30 | Diomed, Ltd. | 2005 | — |
| −2 | K090126 | Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP… | Fotona D.D. | 2009 | — |
| −1 | K101306 | SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models… | Fotona D.D. | 2011 | — |
| 0 (this device) | K150140 | MCL 31 Dermablate | Asclepion Laser Technologies GmbH | 2015 | — |
| +1 | K210634 | MCL 31 Dermablate System | Asclepion Laser Technologies GmbH | 2022 | — |
| +1 | K153229 | Superbium | Bios S.R.L. | 2016 | — |
| +1 | K252561 | BTL-754FF | BTL Industries, Inc. | 2026 | — |
| +2 | K241600 | Dermablate | Asclepion Laser Technologies GmbH | 2024 | — |
| +2 | K213761 | Joule diVa System | Sciton, Inc | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 8 | 0 |
| 1996 | 15 | 0 |
| 1997 | 17 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 13 | 0 |
| 2001 | 12 | 0 |
| 2002 | 18 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 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? (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 |
|---|---|---|---|
| * | K081541 | Dermablate EffectSummary page 5…79-GEX 21 CFR 878.4810 Regulatory Class: Class II Product Codes: GEX Equivalent Devices: K081541 Dermablate Effect (Asclepion Laser Technologies) K101306 Fotona Dynamis Er:YAG Laser Syste… | 2009 |
| * | K101306 | SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Summary page 5…Class: Class II Product Codes: GEX Equivalent Devices: K081541 Dermablate Effect (Asclepion Laser Technologies) K101306 Fotona Dynamis Er:YAG Laser System (Fotona) Device Description: The MCL 31 Dermablate is a pulsed Er:YAG laser emitt… | 2011 |
What descends from it? (7)
5 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 6 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 151 ancestors have a recall of any class.
- Of its descendants, K210634 (Asclepion Laser Technologies GmbH, 2022) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K081541.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes).
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/K150140 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150140: MCL 31 Dermablate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150140
Report an extraction error
Are you the manufacturer?
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