510(k) · Cleared
ClearedSharplan Erbium: Yag Laser (4020)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sharplan Lasers, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jul 23, 1997 as substantially equivalent to K954013 (Schwartz Electro-Optics, Inc., 1996) and 3 other predicates after a 79-day review. Its family tree reaches back 3 generations to 1996. 58 later devices descend from it.
- Decided
- Jul 23, 1997
- Review
- 79 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K954013 (1996). 5 ancestors in all. 58 later devices descend from it, 2 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 backK964128 MCL 29 Dermablate Erbium Laser SystemAesculap-Meditec GmbH · 1997
- This deviceK971648 Sharplan Erbium: Yag Laser (4020)Sharplan Lasers, Inc. · 1997
- Descendant · cites it directly · 56 of its ownK981438 Dornier Medilas EDornier Surgical Products, Inc. · 1998
- Descendant · 2 generations on · 53 of its ownK050317 Burane XLWavelight Laser Technologie AG · 2005
- Descendant · 2 generations on · 52 of its ownK052806 BuraneWavelight Laser Technologie AG · 2005
- Descendant · 3 generations on · 51 of its ownK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- Descendant · 4 generations on · 47 of its ownK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K981438Dornier Medilas EDornier Surgical Products, Inc. · 1998 · cites it directly56descendants
- K050317Burane XLWavelight Laser Technologie AG · 2005 · 2 generations on53descendants
- K052806BuraneWavelight Laser Technologie AG · 2005 · 2 generations on52descendants
- K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 3 generations on51descendants
- K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · 4 generations on47descendants
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 | K964128 | MCL 29 Dermablate Erbium Laser System | Aesculap-Meditec GmbH | 1997 | — |
| 0 (this device) | K971648 | Sharplan Erbium: Yag Laser (4020) | Sharplan Lasers, Inc. | 1997 | — |
| +1 | K981438 | Dornier Medilas E | Dornier Surgical Products, Inc. | 1998 | — |
| +2 | K050317 | Burane XL | Wavelight Laser Technologie AG | 2005 | — |
| +2 | K052806 | Burane | Wavelight Laser Technologie AG | 2005 | — |
| +3 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| +4 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2005 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K954013 | Trilase 2940 Erbium LaserSummary page 1…ector of Regulatory Affairs/Quality Assurance May 2, 1997 2. Model: Sharplan Model 4020 Erbium YAG Laser 3. Predicate Devices: SEO Medical Model 2940 Erbium YAG Laser (K954013), Candela (Fotona) SkinLight Er:YAG Laser (K962902), Con Bio Erbium/2.94 Laser (K961748), ESC Derma 20 Erbium:YAG Laser (cleared… | 1996 |
| * | K962902 | Fotona Skinlight Laser SystemSummary page 1…, 1997 2. Model: Sharplan Model 4020 Erbium YAG Laser 3. Predicate Devices: SEO Medical Model 2940 Erbium YAG Laser (K954013), Candela (Fotona) SkinLight Er:YAG Laser (K962902), Con Bio Erbium/2.94 Laser (K961748), ESC Derma 20 Erbium:YAG Laser (cleared April, 1997), and Asculap MCL 29 Erbium:YAG Laser (… | 1997 |
| * | K961748 | Medlite/Erbium Laser SystemSummary page 1…Erbium YAG Laser 3. Predicate Devices: SEO Medical Model 2940 Erbium YAG Laser (K954013), Candela (Fotona) SkinLight Er:YAG Laser (K962902), Con Bio Erbium/2.94 Laser (K961748), ESC Derma 20 Erbium:YAG Laser (cleared April, 1997), and Asculap MCL 29 Erbium:YAG Laser (K964128). 4. Description: The Sharpl… | 1996 |
| * | K964128 | MCL 29 Dermablate Erbium Laser SystemSummary page 1…(Fotona) SkinLight Er:YAG Laser (K962902), Con Bio Erbium/2.94 Laser (K961748), ESC Derma 20 Erbium:YAG Laser (cleared April, 1997), and Asculap MCL 29 Erbium:YAG Laser (K964128). 4. Description: The Sharplan Model 4020 Erbium YAG Surgical Laser is a medical device which capable of emitting an invisible p… | 1997 |
| * | — | ESC Derma 20 Erbium:YAG Laser Named without a submission number |
What descends from it? (58)
See all 582 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 1 year and passes through 4 companies; a new generation was cleared every 6 months on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K981438 (Dornier Surgical Products, Inc., 1998) has gone furthest, with 56 descendants of its own.
- 13 other devices also cite its predicate K954013.
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 Sharplan Model 4020 Erbium:YAG Surgical Laser System is intended for
incision/excision, ablation, vaporization, and/or coagulation of soft tissue in Plastic Surgery/Dermatology.
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/K971648 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971648: Sharplan Erbium: Yag Laser (4020).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971648
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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