510(k) Report

510(k) · Cleared

Cleared

Acme Medical Aesthetic ND:Yag Laser

K991798510(k) TraditionalCleared Mar 6, 2000285-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

Altus Medical · GEX Powered Laser Surgical Instrument

Cleared on Mar 6, 2000 as substantially equivalent to K973324 (Star Medical Technologies, Inc., 1997) and 2 other predicates after a 285-day review. Its family tree reaches back 4 generations to 1996. 745 later devices descend from it.

Decided
Mar 6, 2000
Review
285 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K963094 (1996). 10 ancestors in all, the oldest K950019 (1995). 745 later devices descend from it, 10 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 4 other ancestors1996: 1 other ancestor1995: 1 other ancestor2002: 7 descendants cleared2003: 8 descendants cleared2016: 39 descendants cleared2005: 5 descendants cleared2011: 25 descendants cleared2014: 32 descendants cleared2004: 6 descendants cleared2025: 84 descendants cleared2007: 16 descendants cleared2022: 54 descendants cleared2006: 6 descendants cleared2008: 26 descendants cleared2012: 22 descendants cleared2017: 33 descendants cleared2009: 16 descendants cleared2010: 19 descendants cleared2015: 27 descendants cleared2013: 29 descendants cleared2018: 33 descendants cleared2020: 42 descendants cleared2023: 42 descendants cleared2019: 24 descendants cleared2021: 32 descendants cleared2026: 47 descendants cleared2024: 71 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. · 19981995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 2 other ancestors 1 generation forward: 10 descendants2 generations forward: 20 descendants3 generations forward: 40 descendants4 generations forward: 83 descendants5 generations forward: 137 descendants6 generations forward: 122 descendants7 generations forward: 92 descendants8 generations forward: 94 descendants9 generations forward: 65 descendants10 generations forward: 45 descendants11 generations forward: 30 descendants12 generations forward: 6 descendants13 generations forward: 1 descendant K981351 · 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. · 19960+5+10
  1. Root · 4 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
  2. 3 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
  3. 2 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
  4. 1 generation backK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
  5. This deviceK991798 Acme Medical Aesthetic ND:Yag LaserAltus Medical · 2000
  6. Descendant · cites it directly · 739 of its ownK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
  7. Descendant · cites it directly · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
  8. Descendant · 2 generations on · 656 of its ownK022923 Candela Gentle Yag Laser SystemCandela Corp. · 2003
  9. Descendant · 2 generations on · 656 of its ownK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
  10. Descendant · 3 generations on · 654 of its ownK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003

Showing 5 of 745 descendants. See all descendants

Descendants cleared per year

2002: 72003: 82004: 62005: 52006: 62007: 162008: 262009: 162010: 192011: 252012: 222013: 292014: 322015: 272016: 392017: 332018: 332019: 242020: 422021: 322022: 542023: 422024: 712025: 842026: 47
2002high 84 (2025) · low 5 (2005)2026

Most influential descendants

Showing 5 of 745 · See all
  • K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc. · 2002 · cites it directly739descendants
  • K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc. · 2002 · cites it directly665descendants
  • K022923Candela Gentle Yag Laser SystemCandela Corp. · 2003 · 2 generations on656descendants
  • K023193Candela Gentle Yag Laser SystemCandela Corp. · 2002 · 2 generations on656descendants
  • K033172Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003 · 3 generations on654descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K963094Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc.1996—
−3K972767Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp.19971
−2K974381Candela Gentlelase GL Dermatological LaserCandela Corp.1998—
−1K981351Candela Gentlelase GL Dermatological LaserCandela Corp.1998—
0 (this device)K991798Acme Medical Aesthetic ND:Yag LaserAltus Medical2000—
+1K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide…Altus Medical, Inc.2002—
+1K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…Altus Medical, Inc.2002—
+2K022923Candela Gentle Yag Laser SystemCandela Corp.2003—
+2K023193Candela Gentle Yag Laser SystemCandela Corp.2002—
+3K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199610
199740

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200270
200380
200460
200550
200660
2007160
2008260
2009160
2010190
2011250
2012220
2013290
2014320
2015270
2016390
2017330
2018330
2019240
2020420
2021320
2022540
2023420
2024710
2025840
2026470
FIG. 1 — Lineage of K991798, 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), 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? (3)

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
*K973324Starlight Pulsed Diode Array Laser System
Summary page 1
…tic Nd:YAG Laser Primary Classification Name: Laser Powered Surgical Instrument (and Accessories) III. Predicate Devices o Star Medical LightSheer Diode Laser System (K973324); e Cynosure Apogee Long Pulse Infrared Laser (K971737); and Candela GentleLase GL Dermatological Laser (K981351). IV. Product…
Star Medical Technologies, Inc.1997—
*K971737Cynosure Photogenica Lpir Dermatological Laser
Summary page 1
…owered Surgical Instrument (and Accessories) III. Predicate Devices o Star Medical LightSheer Diode Laser System (K973324); e Cynosure Apogee Long Pulse Infrared Laser (K971737); and Candela GentleLase GL Dermatological Laser (K981351). IV. Product Description AcTes v Medical Aesthetic Nd:YAG Laser Kit…
Cynosure, Inc.1997—
*K981351Candela Gentlelase GL Dermatological Laser
Summary page 1
…e Devices o Star Medical LightSheer Diode Laser System (K973324); e Cynosure Apogee Long Pulse Infrared Laser (K971737); and Candela GentleLase GL Dermatological Laser (K981351). IV. Product Description AcTes v Medical Aesthetic Nd:YAG Laser Kits are comprised of the following main components: a laser…
Candela Corp.1998—

Also cleared against K973324: 10 other devices →

What descends from it? (745)

See all 745

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

NumberDeviceApplicantDecidedDescendants
K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc.2002739
K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665
K020697Depilase Twin Yag Laser SystemDepilase Group, Ltd.2002229
K023881Profile 1064 Laser SystemSciton, Inc2003227
K032220Adept 1064/532 LaserAdept Medical Concepts2003126
K020412Depilase Twin Lase Laser SystemDepilase Group, Ltd.2002106
K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104
K020463Depilase Yag Lase Plus Laser SystemDepilase Group, Ltd.20021
K032221Adept 1064/755 LaserAdept Medical Concepts20030
K030508Depilase Trio Lase Laser SystemDepilase Group, Ltd.20030

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 4 years and passes through 3 companies; a new generation was cleared every 12 months on median.
  • 1 of the 10 ancestors has a recall of any class.
  • Of its descendants, K014040 (Altus Medical, Inc., 2002) has gone furthest, with 739 descendants of its own.
  • 10 other devices also cite its predicate K973324.

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 Altus Medical Aesthetic Nd:YAG Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology for: the removal of unwanted hair in Fitzpatrick skin types I-V.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K973324

10 other devices cite the same predicate.

  • K090762LEDAQuantel Derma GmbH · 2009
  • K053527Spectra Hair Removal LaserSpectragenics, Inc. · 2008
  • K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
  • K052848Spectra Hair Removal LaserSpectragenics, Inc. · 2005
  • K032846Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
  • K011747Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001

More from Altus Medical

2 FDA decisions under this applicant name. See the company

  • K003202Family of Altus Medical Coolglide Aesthetic Lasers, Models I & IIAltus Medical · 2001

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/K991798 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991798: Acme Medical Aesthetic ND:Yag Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991798

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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