510(k) Report

510(k) · Cleared

Cleared

Cynosure Photogenica LP Dermatological Vascular Lesion Laser

K963094510(k) TraditionalCleared Dec 16, 1996130-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

Cynosure, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Dec 16, 1996 after a 130-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1,185 later devices descend from it.

Decided
Dec 16, 1996
Review
130 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
0

1,185 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1997: 3 descendants cleared1998: 3 descendants cleared2004: 16 descendants cleared1999: 4 descendants cleared2009: 31 descendants cleared2011: 33 descendants cleared2000: 4 descendants cleared2008: 46 descendants cleared2014: 43 descendants cleared2002: 10 descendants cleared2003: 18 descendants cleared2005: 22 descendants cleared2016: 54 descendants cleared2025: 128 descendants cleared2007: 27 descendants cleared2022: 82 descendants cleared2006: 25 descendants cleared2015: 45 descendants cleared2018: 49 descendants cleared2012: 29 descendants cleared2013: 42 descendants cleared2019: 42 descendants cleared2020: 55 descendants cleared2017: 56 descendants cleared2010: 30 descendants cleared2021: 50 descendants cleared2023: 67 descendants cleared2026: 77 descendants cleared2024: 94 descendants cleared1995200020052010201520202025
  1. This deviceK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
  2. Descendant · cites it directly · 1,179 of its ownK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
  3. Descendant · 2 generations on · 1,178 of its ownK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
  4. Descendant · 3 generations on · 1,062 of its ownK990417 DermacoolOptomed Corp. · 1999
  5. Descendant · 4 generations on · 1,046 of its ownK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
  6. Descendant · 5 generations on · 856 of its ownK030527 Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003

Showing 5 of 1,185 descendants. See all descendants

Descendants cleared per year

1997: 31998: 31999: 42000: 42002: 102003: 182004: 162005: 222006: 252007: 272008: 462009: 312010: 302011: 332012: 292013: 422014: 432015: 452016: 542017: 562018: 492019: 422020: 552021: 502022: 822023: 672024: 942025: 1282026: 77
1997high 128 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 1,185 · See all
  • K972767Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · cites it directly1,179descendants
  • K974381Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998 · 2 generations on1,178descendants
  • K990417DermacoolOptomed Corp. · 1999 · 3 generations on1,062descendants
  • K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002 · 4 generations on1,046descendants
  • K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003 · 5 generations on856descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K963094Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc.1996—
+1K972767Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp.19971
+2K974381Candela Gentlelase GL Dermatological LaserCandela Corp.1998—
+3K990417DermacoolOptomed Corp.1999—
+4K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc.2002—
+5K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199730
199830
199940
200040
2002100
2003180
2004160
2005220
2006250
2007270
2008460
2009310
2010300
2011330
2012290
2013420
2014430
2015450
2016540
2017560
2018490
2019420
2020550
2021500
2022820
2023670
2024940
20251280
2026770
FIG. 1 — Lineage of K963094, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1,185)

See all 1,185

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

NumberDeviceApplicantDecidedDescendants
K972767Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp.19971,179
K971874Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc.1997816
K981351Candela Gentlelase GL Dermatological LaserCandela Corp.1998811

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, K972767 (Candela Corp., 1997) has gone furthest, with 1,179 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 Cynosure, Inc.

98 FDA decisions under this applicant name. See the company

  • K190678TempSureCynosure, Inc. · 2019
  • K182365TempSure SystemCynosure, Inc. · 2018
  • K173199PicoSure WorkstationCynosure, Inc. · 2018
  • K171992SculpSureCynosure, Inc. · 2017
  • K171262TempSureCynosure, Inc. · 2017

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https://510kreport.com/device/K963094 · printed Nov 5, 2026

Cite this page

510(k) Report. “K963094: Cynosure Photogenica LP Dermatological Vascular Lesion Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963094

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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