510(k) · Cleared
ClearedSharplan Lasers, Inc. Silktouch Flash Scanner
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 Apr 26, 1996 as substantially equivalent to K936109 (Sharplan Lasers, Inc., 1994) and 1 other predicate after an 81-day review. Its family tree reaches back 1 generation to 1994. 677 later devices descend from it.
- Decided
- Apr 26, 1996
- Review
- 81 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K936109 (1994). 2 ancestors in all. 677 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- This deviceK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- Descendant · cites it directly · 675 of its ownK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- Descendant · 2 generations on · 653 of its ownK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- Descendant · cites it directly · 376 of its ownK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
- Descendant · 3 generations on · 350 of its ownK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- Descendant · 4 generations on · 342 of its ownK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
Showing 5 of 677 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 677 · See all- K963339Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997 · cites it directly675descendants
- K974789Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998 · 2 generations on653descendants
- K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesLumenis, Inc. · 2002 · cites it directly376descendants
- K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND…Lumenis, Inc. · 1999 · 3 generations on350descendants
- K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis · 2001 · 4 generations on342descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| 0 (this device) | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| +1 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| +2 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| +1 | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device… | Lumenis, Inc. | 2002 | — |
| +3 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| +4 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 10 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 6 | 0 |
| 2007 | 11 | 0 |
| 2008 | 22 | 0 |
| 2009 | 12 | 0 |
| 2010 | 20 | 0 |
| 2011 | 27 | 0 |
| 2012 | 26 | 0 |
| 2013 | 32 | 0 |
| 2014 | 27 | 0 |
| 2015 | 26 | 0 |
| 2016 | 38 | 0 |
| 2017 | 27 | 0 |
| 2018 | 32 | 0 |
| 2019 | 21 | 0 |
| 2020 | 43 | 0 |
| 2021 | 31 | 0 |
| 2022 | 46 | 0 |
| 2023 | 38 | 0 |
| 2024 | 51 | 0 |
| 2025 | 61 | 0 |
| 2026 | 44 | 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 |
|---|---|---|---|
| * | K936109 | Sharplan Model 1120 CO2 Surgical LaserSummary page 1…Robbins Acrotorque & Bell Hand Engines, the Sharplan Model 1120 CO2 Surgical Laser, and the Sharplan SwiftL.ase CO2 Flash Scanner Accessory (aka SilkTouch) (preamended, K936109, K941312, and K936109, respectively). It is indicated for incision/excision, ablation/vaporization, coagulation, and debridement… | 1994 |
| * | K941312 | Sharplan Swiftlase 765/766/767 FlashscanSummary page 1…Acrotorque & Bell Hand Engines, the Sharplan Model 1120 CO2 Surgical Laser, and the Sharplan SwiftL.ase CO2 Flash Scanner Accessory (aka SilkTouch) (preamended, K936109, K941312, and K936109, respectively). It is indicated for incision/excision, ablation/vaporization, coagulation, and debridement of soft t… | 1994 |
What descends from it? (677)
See all 6775 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K963339 | Coherent Ultrapulse CO2 Surgical Lasers | 1997 | 675 |
| K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories | 2002 | 376 |
| K063001 | Slim Evolution Family of CO2 Lasers and Delivery Device Accessories | 2007 | 63 |
| K980398 | Kaplan Pendulaser 115 Surgical Laser with Optoscan II | 1998 | 0 |
| K974633 | Scantech Laser Scanner | 1998 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K963339 (Coherent Medical Group, 1997) has gone furthest, with 675 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?
It is indicated for incision/excision, ablation/vaporization, coagulation, and debridement of soft tissue in Plastic Surgery/Dermatology. Plastic Surgery/Dermatology procedures encountered are: laser skin resurfacing/dermabrasion, blepharoplasty, rhinophyma, squamous cell carcinoma, buccal hemangioma, telangjectasis, the treatment of wrinkles or rhytides, and scar revision.
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/K960521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960521: Sharplan Lasers, Inc. Silktouch Flash Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960521
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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