510(k) · Cleared
ClearedDermablate ER: Yag Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap-Meditec North America · GEX Powered Laser Surgical Instrument
Cleared on Apr 21, 1998 as substantially equivalent to K961748 (Continuum Biomedical, Inc., 1996) and 1 other predicate after an 82-day review. Its family tree reaches back 2 generations to 1996. 178 later devices descend from it.
- Decided
- Apr 21, 1998
- Review
- 82 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954013 (1996). 3 ancestors in all. 178 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK954013 Trilase 2940 Erbium LaserSchwartz Electro-Optics, Inc. · 1996
- 1 generation backK961748 Medlite/Erbium Laser SystemContinuum Biomedical, Inc. · 1996
- This deviceK980361 Dermablate ER: Yag Laser SystemAesculap-Meditec North America · 1998
- Descendant · cites it directly · 160 of its ownK063571 Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc. · 2007
- Descendant · 2 generations on · 159 of its ownK071152 Palomar Erbium HandpiecePalomar Medical Products, Inc. · 2007
- Descendant · 2 generations on · 158 of its ownK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- Descendant · 3 generations on · 157 of its ownK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- Descendant · 2 generations on · 156 of its ownK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
Showing 5 of 178 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 178 · See all- K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc. · 2007 · cites it directly160descendants
- K071152Palomar Erbium HandpiecePalomar Medical Products, Inc. · 2007 · 2 generations on159descendants
- K083900Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009 · 2 generations on158descendants
- K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010 · 3 generations on157descendants
- K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010 · 2 generations on156descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954013 | Trilase 2940 Erbium Laser | Schwartz Electro-Optics, Inc. | 1996 | — |
| −1 | K961748 | Medlite/Erbium Laser System | Continuum Biomedical, Inc. | 1996 | — |
| 0 (this device) | K980361 | Dermablate ER: Yag Laser System | Aesculap-Meditec North America | 1998 | — |
| +1 | K063571 | Palomar LUX2940 Handpiece | Palomar Medical Technologies, Inc. | 2007 | — |
| +2 | K071152 | Palomar Erbium Handpiece | Palomar Medical Products, Inc. | 2007 | — |
| +2 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| +3 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| +2 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
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 | 2 | 0 |
| 2003 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 7 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 7 | 0 |
| 2017 | 7 | 0 |
| 2018 | 10 | 0 |
| 2019 | 6 | 0 |
| 2020 | 16 | 0 |
| 2021 | 10 | 0 |
| 2022 | 20 | 0 |
| 2023 | 13 | 0 |
| 2024 | 19 | 0 |
| 2025 | 22 | 0 |
| 2026 | 12 | 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 |
|---|---|---|---|
| * | K961748 | Medlite/Erbium Laser SystemSummary page 2…ablate laser is substantially equivalent to legally marketed predicate devices, i.e., the MCL 29 Dermablate and the Continuum Biomed, Inc. Multilite erbium laser system (K961748 and K970934). 081 o WEALTH ¢, SERVICE; o T ) 1 < 1'3~ “Wvara C DEPARTMENT OF HEALTH & HUMAN SERVICES Public H… | 1996 |
| * | K970934 | CB Erbium/2.94(TM) ER:Yag LaserSummary page 2…is substantially equivalent to legally marketed predicate devices, i.e., the MCL 29 Dermablate and the Continuum Biomed, Inc. Multilite erbium laser system (K961748 and K970934). 081 o WEALTH ¢, SERVICE; o T ) 1 < 1'3~ “Wvara C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Servic… | 1997 |
What descends from it? (178)
See all 1782 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 2 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K063571 (Palomar Medical Technologies, Inc., 2007) has gone furthest, with 160 descendants of its own.
- 9 other devices also cite its predicate K961748.
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 Dermablate laser 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).
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/K980361 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980361: Dermablate 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/K980361
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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