510(k) Report

510(k) · Cleared

Cleared

Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPX

K032991510(k) TraditionalCleared Sep 14, 2004355-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

Light Age, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Sep 14, 2004 as substantially equivalent to K983977 (Light Age, Inc., 1999) and 8 other predicates after a 355-day review. Its family tree reaches back 6 generations to 1996. 61 later devices descend from it.

Decided
Sep 14, 2004
Review
355 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
9

Its longest line of descent runs back 6 generations to K963094 (1996). 22 ancestors in all, the oldest K950019 (1995). 61 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 3 other ancestors2001: 1 other ancestor2000: 1 other ancestor1999: 3 other ancestors1997: 5 other ancestors1998: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor2009: 2 descendants cleared2014: 1 descendant cleared2012: 1 descendant cleared2022: 10 descendants cleared2019: 4 descendants cleared2015: 3 descendants cleared2020: 8 descendants cleared2018: 3 descendants cleared2023: 6 descendants cleared2026: 5 descendants cleared2024: 8 descendants cleared2021: 3 descendants cleared2017: 2 descendants cleared2025: 5 descendants clearedK963094 · Cynosure Photogenica LP Dermatological Vascular Lesion Laser · Cynosure, Inc. · 1996×2: 2 generations cleared close together, K972767 (1997), K974381 (1998) K981351 · Candela Gentlelase GL Dermatological Laser · Candela Corp. · 1998K994260 · Candela Gentlelase GL Dermatological Laser · Candela Corp. · 2000K024335 · Candela Gentlelase Family of Laser Systems · Candela Corp. · 2003 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors3 generations back: 3 other ancestors4 generations back: 3 other ancestors5 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 7 descendants4 generations forward: 17 descendants5 generations forward: 21 descendants6 generations forward: 11 descendants7 generations forward: 1 descendant K024335 · Candela Gentlelase Family of Laser Systems · Candela Corp. · 2003 · recalledK994260 · Candela Gentlelase GL Dermatological Laser · Candela Corp. · 2000K981351 · Candela Gentlelase GL Dermatological Laser · Candela Corp. · 1998K974381 · Candela Gentlelase GL Dermatological Laser · Candela Corp. · 1998K972767 · Candela Gentlelase GL Dermatological Vascular Lesion Laser · Candela Corp. · 1997 · recalledK963094 · Cynosure Photogenica LP Dermatological Vascular Lesion Laser · Cynosure, Inc. · 1996−50+5
  1. Root · 6 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
  2. 5 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
  3. 4 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
  4. 3 generations backK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
  5. 2 generations backK994260 Candela Gentlelase GL Dermatological LaserCandela Corp. · 2000
  6. 1 generation backK024335 Candela Gentlelase Family of Laser SystemsCandela Corp. · 2003 · Recalled
  7. This deviceK032991 Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP…Light Age, Inc. · 2004
  8. Descendant · cites it directly · 58 of its ownK090571 Alma Lasers ALEX755 ModuleAlma Lasers, Ltd. · 2009
  9. Descendant · 2 generations on · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
  10. Descendant · 3 generations on · 32 of its ownK143519 The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015
  11. Descendant · 3 generations on · 22 of its ownK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
  12. Descendant · 4 generations on · 14 of its ownK222064 The Alma Soprano TitaniumAlma Lasers, Inc. · 2022

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

2009: 22012: 12014: 12015: 32017: 22018: 32019: 42020: 82021: 32022: 102023: 62024: 82025: 52026: 5
2009high 10 (2022) · low 0 (2010)2026

Most influential descendants

Showing 5 of 61 · See all
  • K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd. · 2009 · cites it directly58descendants
  • K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · 2 generations on57descendants
  • K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015 · 3 generations on32descendants
  • K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc. · 2018 · 3 generations on22descendants
  • K222064The Alma Soprano TitaniumAlma Lasers, Inc. · 2022 · 4 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K963094Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc.1996—
−5K972767Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp.19971
−4K974381Candela Gentlelase GL Dermatological LaserCandela Corp.1998—
−3K981351Candela Gentlelase GL Dermatological LaserCandela Corp.1998—
−2K994260Candela Gentlelase GL Dermatological LaserCandela Corp.2000—
−1K024335Candela Gentlelase Family of Laser SystemsCandela Corp.20031
0 (this device)K032991Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPXLight Age, Inc.2004—
+1K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd.2009—
+2K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.2014—
+3K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH2015—
+3K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology…Alma Lasers, Inc.2018—
+4K222064The Alma Soprano TitaniumAlma Lasers, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199610
199750
199810
199930
200010
200110
200330

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201210
201410
201530
201720
201830
201940
202080
202130
2022100
202360
202480
202550
202650
FIG. 1 — Lineage of K032991, 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), 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. #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? (9)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K983977Light Age Epicare Alexandrite Laser
Summary page 2
…ion: Medical Device Class: Regulatory Class II Laser Safety Class: Class IV Laser Product Predicate Devices: - Light AgeTM EpiCare TM Alexandrite Laser (K983977) - CandelaTm GentleLASE Alexandrite Laser (K024260, K024335 & K024371) - CynosureTM Apogee-TKS Alexandrite Laser (K…
Light Age, Inc.1999—
*K024260Candela Gentlelase Family of Laser Systems
Summary page 2
…er Safety Class: Class IV Laser Product Predicate Devices: - Light AgeTM EpiCare TM Alexandrite Laser (K983977) - CandelaTm GentleLASE Alexandrite Laser (K024260, K024335 & K024371) - CynosureTM Apogee-TKS Alexandrite Laser (K992757) - CynosureTM Apogee-TKS II Alexandrite Lase…
Candela Corp.20031
*K024335Candela Gentlelase Family of Laser Systems
Summary page 2
…Class: Class IV Laser Product Predicate Devices: - Light AgeTM EpiCare TM Alexandrite Laser (K983977) - CandelaTm GentleLASE Alexandrite Laser (K024260, K024335 & K024371) - CynosureTM Apogee-TKS Alexandrite Laser (K992757) - CynosureTM Apogee-TKS II Alexandrite Laser (K03148…
Candela Corp.20031
*K024371Candela Gentle Lase Family of Laser System
Summary page 2
…ass IV Laser Product Predicate Devices: - Light AgeTM EpiCare TM Alexandrite Laser (K983977) - CandelaTm GentleLASE Alexandrite Laser (K024260, K024335 & K024371) - CynosureTM Apogee-TKS Alexandrite Laser (K992757) - CynosureTM Apogee-TKS II Alexandrite Laser (K031488) -…
Candela Corp.2003—
*K992757Cynosure Apogee-TKS Dermatological Laser
Summary page 2
…eTM EpiCare TM Alexandrite Laser (K983977) - CandelaTm GentleLASE Alexandrite Laser (K024260, K024335 & K024371) - CynosureTM Apogee-TKS Alexandrite Laser (K992757) - CynosureTM Apogee-TKS II Alexandrite Laser (K031488) - Sharplan TM Model 5000 Alexandrite Laser (K971874 & K9733…
Cynosure, Inc.2000—
*K031488Cynosure Apogee-TKS II Dermatological Laser
Summary page 2
…GentleLASE Alexandrite Laser (K024260, K024335 & K024371) - CynosureTM Apogee-TKS Alexandrite Laser (K992757) - CynosureTM Apogee-TKS II Alexandrite Laser (K031488) - Sharplan TM Model 5000 Alexandrite Laser (K971874 & K973354) - LumenisTM LightSheerTMi Pulsed Diode Laser (K0036…
Cynosure, Inc.2003—
*K971874Sharplan Epitouch Alexandrite Laser System (5000)
Summary page 2
…- CynosureTM Apogee-TKS Alexandrite Laser (K992757) - CynosureTM Apogee-TKS II Alexandrite Laser (K031488) - Sharplan TM Model 5000 Alexandrite Laser (K971874 & K973354) - LumenisTM LightSheerTMi Pulsed Diode Laser (K003614) Description: The Light Age EpiCareTM Alexandrite Laser…
Sharplan Lasers, Inc.1997—
*K973354Sharplan Epitouch Alexandrite Laser System (5000)
Summary page 2
…osureTM Apogee-TKS Alexandrite Laser (K992757) - CynosureTM Apogee-TKS II Alexandrite Laser (K031488) - Sharplan TM Model 5000 Alexandrite Laser (K971874 & K973354) - LumenisTM LightSheerTMi Pulsed Diode Laser (K003614) Description: The Light Age EpiCareTM Alexandrite Laser has an Al…
Sharplan Lasers, Inc.1997—
*K003614Lightsheer Pulsed Diode Array Laser System
Summary page 2
…reTM Apogee-TKS II Alexandrite Laser (K031488) - Sharplan TM Model 5000 Alexandrite Laser (K971874 & K973354) - LumenisTM LightSheerTMi Pulsed Diode Laser (K003614) Description: The Light Age EpiCareTM Alexandrite Laser has an Alexandrite crystal rod as a lasing…
Coherent Star20012

Also cleared against K983977: 1 other device →

What descends from it? (61)

See all 61

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

NumberDeviceApplicantDecidedDescendants
K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd.200958
K091625Epicare-Duo Laser SystemLight Age, Inc.20091

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 8 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
  • 4 of the 22 ancestors have a recall of any class.
  • Of its descendants, K090571 (Alma Lasers, Ltd., 2009) has gone furthest, with 58 descendants of its own.
  • 1 other device also cites its predicate K983977.

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—

What is it indicated for?

The Light Age EpiCareTM Alexandrite Laser is indicated for stable long-term, or

permanent hair reduction. Permanent hair reduction is defined as long-term stable

reduction in the number of hairs re-growing after a treatment regime. It is used for all

skin types (Fitzpatrick I-VI) including tanned skin.

It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and

wrinkles.

Indications for use as stated in the FDA summary.

Also cleared against K983977

1 other device cites the same predicate.

  • K042474ARIONWavelight Laser Technologie AG · 2004

More from Light Age, Inc.

7 FDA decisions under this applicant name. See the company

  • K113115Epicare YagLight Age, Inc. · 2012
  • K110370Q-ClearLight Age, Inc. · 2011
  • K091625Epicare-Duo Laser SystemLight Age, Inc. · 2009
  • K033259Light Age Q-Clear Laser, Model 701-1101Light Age, Inc. · 2004
  • K983977Light Age Epicare Alexandrite LaserLight Age, Inc. · 1999

Recent decisions in GEX

The GEX category page

  • K262701PicoPeak Picosecond Nd:Yag Laser System (Bella-9)Beijing Sea Heart International Science and Technologyco.Ltd · 2026
  • K262628Picosecond Laser treatment system (Z180)Sanhe PERFECTLASER Technology Co., Ltd. · 2026
  • K261572Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)Keyue (Hangzhou) Medical Information Technology Co., Ltd. · 2026
  • K262346CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight…Wuhan Phomed Technology Co., Ltd. · 2026
  • K261692Diode Laser Hair Removal Machine (QDTM-03)Beijing Nubway S&T Co., Ltd. · 2026

https://510kreport.com/device/K032991 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032991: Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032991

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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