510(k) Report

510(k) · Cleared

Cleared

Sharplan Lasers, Inc Silktouch 2 Flash Scanner

K955621510(k) TraditionalCleared Feb 27, 199678-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sharplan Lasers, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Feb 27, 1996 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 677 later devices descend from it.

Decided
Feb 27, 1996
Review
78 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
0

677 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared1998: 3 descendants cleared2002: 10 descendants cleared2007: 11 descendants cleared2004: 6 descendants cleared2025: 61 descendants cleared2008: 22 descendants cleared2006: 6 descendants cleared2005: 6 descendants cleared2003: 6 descendants cleared2009: 12 descendants cleared2013: 32 descendants cleared2010: 20 descendants cleared2012: 26 descendants cleared2015: 26 descendants cleared2011: 27 descendants cleared2021: 31 descendants cleared2014: 27 descendants cleared2016: 38 descendants cleared2018: 32 descendants cleared1999: 1 descendant cleared2022: 46 descendants cleared2024: 51 descendants cleared2020: 43 descendants cleared2017: 27 descendants cleared2023: 38 descendants cleared2001: 2 descendants cleared2019: 21 descendants cleared2026: 44 descendants cleared1995200020052010201520202025
  1. This deviceK955621 Sharplan Lasers, Inc Silktouch 2 Flash ScannerSharplan Lasers, Inc. · 1996
  2. Descendant · cites it directly · 675 of its ownK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
  3. Descendant · 2 generations on · 653 of its ownK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
  4. Descendant · cites it directly · 376 of its ownK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
  5. Descendant · 3 generations on · 350 of its ownK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
  6. 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

1997: 21998: 31999: 12001: 22002: 102003: 62004: 62005: 62006: 62007: 112008: 222009: 122010: 202011: 272012: 262013: 322014: 272015: 262016: 382017: 272018: 322019: 212020: 432021: 312022: 462023: 382024: 512025: 612026: 44
1997high 61 (2025) · low 0 (2000)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955621Sharplan Lasers, Inc Silktouch 2 Flash ScannerSharplan Lasers, Inc.1996—
+1K963339Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group1997—
+2K974789Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc.1998—
+1K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device…Lumenis, Inc.2002—
+3K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO…Lumenis, Inc.1999—
+4K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis20012

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199830
199910
200120
2002100
200360
200460
200560
200660
2007110
2008220
2009120
2010200
2011270
2012260
2013320
2014270
2015260
2016380
2017270
2018320
2019210
2020430
2021310
2022460
2023380
2024510
2025610
2026440
FIG. 1 — Lineage of K955621, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (677)

See all 677

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K963339Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group1997675
K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesLumenis, Inc.2002376
K063001Slim Evolution Family of CO2 Lasers and Delivery Device AccessoriesLasering S.R.L.200763
K974633Scantech Laser ScannerPhantom Technologies, Inc.19980

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?

  • Of its descendants, K963339 (Coherent Medical Group, 1997) has gone furthest, with 675 descendants of its own.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

More from Sharplan Lasers, Inc.

78 FDA decisions under this applicant name. See the company

  • K973354Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc. · 1997
  • K972099Sharplan Epitouch Ruby Laser SystemSharplan Lasers, Inc. · 1997
  • K971874Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc. · 1997
  • K971648Sharplan Erbium: Yag Laser (4020)Sharplan Lasers, Inc. · 1997
  • K971743Sharplan CO2 Surgical Laser SystemSharplan Lasers, Inc. · 1997

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https://510kreport.com/device/K955621 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955621: Sharplan Lasers, Inc Silktouch 2 Flash Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955621

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026