510(k) Report

510(k) · Cleared

Cleared

Aurora Surgical Diode Laser System W/Accessories

K954316510(k) TraditionalCleared Dec 15, 199591-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

Premier Laser Systems, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Dec 15, 1995 after a 91-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 382 later devices descend from it.

Decided
Dec 15, 1995
Review
91 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
0

382 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2004: 4 descendants cleared1999: 2 descendants cleared1997: 1 descendant cleared1998: 2 descendants cleared2008: 21 descendants cleared2006: 5 descendants cleared2007: 12 descendants cleared2009: 11 descendants cleared2024: 31 descendants cleared2010: 17 descendants cleared2015: 16 descendants cleared2003: 1 descendant cleared2002: 2 descendants cleared2017: 14 descendants cleared2012: 9 descendants cleared2014: 15 descendants cleared2020: 21 descendants cleared2011: 11 descendants cleared2019: 13 descendants cleared2025: 47 descendants cleared2018: 17 descendants cleared2013: 16 descendants cleared2023: 18 descendants cleared2022: 28 descendants cleared2016: 11 descendants cleared2026: 24 descendants cleared2021: 13 descendants cleared1995200020052010201520202025
  1. This deviceK954316 Aurora Surgical Diode Laser System W/AccessoriesPremier Laser Systems, Inc. · 1995
  2. Descendant · cites it directly · 318 of its ownK974586 Aurora Diode Laser SystemPremier Laser Systems, Inc. · 1998
  3. Descendant · cites it directly · 318 of its ownK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
  4. Descendant · cites it directly · 306 of its ownK040294 Laserpro Diode Laser Systems, Models 810, 940 & 980Photo Medex, Inc. · 2004
  5. Descendant · cites it directly · 303 of its ownK042211 Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSurgical Laser Technologies, Inc. · 2004
  6. Descendant · 2 generations on · 299 of its ownK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006

Showing 5 of 382 descendants. See all descendants

Descendants cleared per year

1997: 11998: 21999: 22002: 22003: 12004: 42006: 52007: 122008: 212009: 112010: 172011: 112012: 92013: 162014: 152015: 162016: 112017: 142018: 172019: 132020: 212021: 132022: 282023: 182024: 312025: 472026: 24
1997high 47 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 382 · See all
  • K974586Aurora Diode Laser SystemPremier Laser Systems, Inc. · 1998 · cites it directly318descendants
  • K972325Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997 · cites it directly318descendants
  • K040294Laserpro Diode Laser Systems, Models 810, 940 & 980Photo Medex, Inc. · 2004 · cites it directly306descendants
  • K042211Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSurgical Laser Technologies, Inc. · 2004 · cites it directly303descendants
  • K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA · 2006 · 2 generations on299descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954316Aurora Surgical Diode Laser System W/AccessoriesPremier Laser Systems, Inc.1995—
+1K974586Aurora Diode Laser SystemPremier Laser Systems, Inc.1998—
+1K972325Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc.1997—
+1K040294Laserpro Diode Laser Systems, Models 810, 940 & 980Photo Medex, Inc.2004—
+1K042211Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSurgical Laser Technologies, Inc.2004—
+2K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories…Intermedic Arfran, SA2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199820
199920
200220
200310
200440
200650
2007120
2008210
2009110
2010170
2011110
201290
2013160
2014150
2015160
2016110
2017140
2018170
2019130
2020210
2021130
2022280
2023180
2024310
2025470
2026240
FIG. 1 — Lineage of K954316, 1995–2026Source: 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? (382)

See all 382

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

NumberDeviceApplicantDecidedDescendants
K974586Aurora Diode Laser SystemPremier Laser Systems, Inc.1998318
K972325Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc.1997318
K040294Laserpro Diode Laser Systems, Models 810, 940 & 980Photo Medex, Inc.2004306
K042211Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSurgical Laser Technologies, Inc.2004303
K991994TwilightBiolase Technology, Inc.1999280
K983058Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc.1998208
K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.20087

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, K974586 (Premier Laser Systems, Inc., 1998) has gone furthest, with 318 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 Premier Laser Systems, Inc.

14 FDA decisions under this applicant name. See the company

  • K993285Aurora SLPremier Laser Systems, Inc. · 1999
  • K992374Aurora HLPremier Laser Systems, Inc. · 1999
  • K992620BlulazePremier Laser Systems, Inc. · 1999
  • K981379AuroraPremier Laser Systems, Inc. · 1998
  • K983211CentauriPremier Laser Systems, Inc. · 1998

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/K954316 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954316: Aurora Surgical Diode Laser System W/Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954316

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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