510(k) Report

510(k) · Cleared

Cleared

Diolite 532

K964074510(k) TraditionalCleared Apr 1, 1997172-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

Iriderm Div. · GEX Powered Laser Surgical Instrument

Cleared on Apr 1, 1997 as substantially equivalent to K954905 (Continuum Biomedical, Inc., 1996) and 3 other predicates after a 172-day review. Its family tree reaches back 2 generations to 1994. 307 later devices descend from it.

Decided
Apr 1, 1997
Review
172 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K933880 (1994). 5 ancestors in all, the oldest K883541 (1988). 307 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1990: 1 other ancestor1988: 1 other ancestor2002: 3 descendants cleared2004: 3 descendants cleared1998: 2 descendants cleared2006: 1 descendant cleared2009: 2 descendants cleared2014: 16 descendants cleared2008: 1 descendant cleared2013: 11 descendants cleared2011: 7 descendants cleared2010: 6 descendants cleared2003: 1 descendant cleared2012: 4 descendants cleared2007: 2 descendants cleared2018: 15 descendants cleared2022: 32 descendants cleared2020: 18 descendants cleared2025: 34 descendants cleared2021: 16 descendants cleared2015: 13 descendants cleared2024: 33 descendants cleared2016: 17 descendants cleared2026: 23 descendants cleared2017: 17 descendants cleared2019: 15 descendants cleared2023: 15 descendants clearedK933880 · SL Series Surgical Laser Systems · Laserscope · 1994K954905 · CB Diode/532 Laser System · Continuum Biomedical, Inc. · 19961990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 8 descendants2 generations forward: 11 descendants3 generations forward: 19 descendants4 generations forward: 60 descendants5 generations forward: 71 descendants6 generations forward: 65 descendants7 generations forward: 38 descendants8 generations forward: 14 descendants9 generations forward: 8 descendants10 generations forward: 4 descendants11 generations forward: 8 descendants12 generations forward: 1 descendant K954905 · CB Diode/532 Laser System · Continuum Biomedical, Inc. · 1996K933880 · SL Series Surgical Laser Systems · Laserscope · 19940+5+10
  1. Root · 2 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
  2. 1 generation backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
  3. This deviceK964074 Diolite 532Iriderm Div. · 1997
  4. Descendant · cites it directly · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
  5. Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
  6. Descendant · 2 generations on · 92 of its ownK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
  7. Descendant · cites it directly · 92 of its ownK020071 Viridis Derma LaserQuantel Medical · 2002
  8. Descendant · 3 generations on · 87 of its ownK121346 Picosure WorkstationCynosure, Inc. · 2012

Showing 5 of 307 descendants. See all descendants

Descendants cleared per year

1998: 22002: 32003: 12004: 32006: 12007: 22008: 12009: 22010: 62011: 72012: 42013: 112014: 162015: 132016: 172017: 172018: 152019: 152020: 182021: 162022: 322023: 152024: 332025: 342026: 23
1998high 34 (2025) · low 0 (1999)2026

Most influential descendants

Showing 5 of 307 · See all
  • K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · cites it directly198descendants
  • K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
  • K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · 2 generations on92descendants
  • K020071Viridis Derma LaserQuantel Medical · 2002 · cites it directly92descendants
  • K121346Picosure WorkstationCynosure, Inc. · 2012 · 3 generations on87descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K933880SL Series Surgical Laser SystemsLaserscope1994—
−1K954905CB Diode/532 Laser SystemContinuum Biomedical, Inc.1996—
0 (this device)K964074Diolite 532Iriderm Div.1997—
+1K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009—
+2K101916Joule Multi-Platform SystemSciton, Inc2011—
+2K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.20101
+1K020071Viridis Derma LaserQuantel Medical2002—
+3K121346Picosure WorkstationCynosure, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199010
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
200230
200310
200430
200610
200720
200810
200920
201060
201170
201240
2013110
2014160
2015130
2016170
2017170
2018150
2019150
2020180
2021160
2022320
2023150
2024330
2025340
2026230
FIG. 1 — Lineage of K964074, 1994–2026Source: 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? (4)

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
*K954905CB Diode/532 Laser System
Summary page 1
…oLite 532 Laser System is substantially equivalent to other currently legally marketed laser devices including the Continuum Biomedical, Inc., CB Diode/532 Laser System (K954905), the Laserscope, Aura Laser System (K951034), and the Innovative Health Concepts, Inc., Vasculase Copper Vapor Laser System (K88…
Continuum Biomedical, Inc.1996—
*K951034Aura Laser System
Summary page 1
…alent to other currently legally marketed laser devices including the Continuum Biomedical, Inc., CB Diode/532 Laser System (K954905), the Laserscope, Aura Laser System (K951034), and the Innovative Health Concepts, Inc., Vasculase Copper Vapor Laser System (K883541, K903883). Intended Use The DioLite 53…
Laserscope1995—
*K883541Metalaser Vasculase
Summary page 1
…l, Inc., CB Diode/532 Laser System (K954905), the Laserscope, Aura Laser System (K951034), and the Innovative Health Concepts, Inc., Vasculase Copper Vapor Laser System (K883541, K903883). Intended Use The DioLite 532 is a semiconductor-based laser system which delivers 532 nm laser light intended to be…
Metatech Corp.1988—
*K903883Vasculase (R) Copper Vapor Laser Syst, Pigment Les
Summary page 1
…CB Diode/532 Laser System (K954905), the Laserscope, Aura Laser System (K951034), and the Innovative Health Concepts, Inc., Vasculase Copper Vapor Laser System (K883541, K903883). Intended Use The DioLite 532 is a semiconductor-based laser system which delivers 532 nm laser light intended to be used for…
Metatech Corp.1990—

Also cleared against K954905: 2 other devices →

What descends from it? (307)

See all 307

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

NumberDeviceApplicantDecidedDescendants
K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198
K020071Viridis Derma LaserQuantel Medical200292
K041930Varilite Laser SystemIridex Corporation200475
K021975Lasersystem Beautystar 532Asclepion-Meditec AG200224
K982031Oculight GL with the Dermatology HandpieceIridex Corp199822
K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042
K062074Iridex Wireless FootswitchIridex Corp20060
K981126Ceralas G Frequency Doubled ND: Yag Laser Systems, Ceralas G3Ceram Optec, 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?

  • The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K083899 (Hoya Conbio, Inc., 2009) has gone furthest, with 198 descendants of its own.
  • 2 other devices also cite its predicate K954905.

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 DioLite 532 is a semiconductor-based laser system which delivers 532 nm laser light intended to be used for the photocoagulation of vascular and pigmented skin lesions.

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 K954905

2 other devices cite the same predicate.

  • K982031Oculight GL with the Dermatology HandpieceIridex Corp · 1998
  • K981126Ceralas G Frequency Doubled ND: Yag Laser Systems, Ceralas G3Ceram Optec, Inc. · 1998

More from Iriderm Div.

10 FDA decisions under this applicant name. See the company

  • K960971Oculight GLIriderm Div. · 1996
  • K960522Diopexy ProbeIriderm Div. · 1996
  • K915236Iris G-ProbeIriderm Div. · 1994
  • K933211D'amico\Peyman Fluted EndoprobeIriderm Div. · 1994
  • K922663Iris Oculight SLIriderm Div. · 1992

Recent decisions in GEX

The GEX category page

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  • 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/K964074 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964074: Diolite 532.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964074

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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