510(k) Report

510(k) · Cleared

Cleared

SDL Diode Laser System

K960905510(k) TraditionalCleared Jun 3, 199690-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

Slt-J, Ltd. · GEX Powered Laser Surgical Instrument

Cleared on Jun 3, 1996 as substantially equivalent to K914197 (L.A.S.E.R., Inc., 1992) and 8 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1990.

Decided
Jun 3, 1996
Review
90 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
10

Its longest line of descent runs back 1 generation to K901365 (1990). 9 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1993: 7 other ancestors1992: 1 other ancestorK901365 · Laser Forceps Handpiece · Lca, Inc. · 199019901992199419961998
Other ancestors, by generation 1 generation back: 8 other ancestors K901365 · Laser Forceps Handpiece · Lca, Inc. · 19900
  1. Root · 1 generation backK901365 Laser Forceps HandpieceLca, Inc. · 1990
  2. This deviceK960905 SDL Diode Laser SystemSlt-J, Ltd. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K901365Laser Forceps HandpieceLca, Inc.1990—
0 (this device)K960905SDL Diode Laser SystemSlt-J, Ltd.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199370
FIG. 1 — Lineage of K960905, 1990–1996Source: 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? (10)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K914197Alloy Scalpel Handpieces
Summary page 2
…tement of Equivalence In the opinion of SLT-J, Ltd., the SDL diode laser system, when used with any of the following fiberoptic delivery systems: NEOS Alloy Scalpel (K#914197) LCA, Inc. (Cincinnati, OH) R yin - Fiber Cap (K#924120) LCA, Inc. (Cincinnati, OH) Hybrid Surgical Device (K#9…
L.A.S.E.R., Inc.1992—
*K924120Molded Fiber Cap Delivery System
Summary page 3
…system, when used with any of the following fiberoptic delivery systems: NEOS Alloy Scalpel (K#914197) LCA, Inc. (Cincinnati, OH) R yin - Fiber Cap (K#924120) LCA, Inc. (Cincinnati, OH) Hybrid Surgical Device (K#924160) LCA, Inc. (Cincinnati, OH) Closed End (K#931070) LCA, Inc. (Cinci…
Lca, Inc.1993—
*K924160Hybrid Surgical Device
Summary page 3
…ry systems: NEOS Alloy Scalpel (K#914197) LCA, Inc. (Cincinnati, OH) R yin - Fiber Cap (K#924120) LCA, Inc. (Cincinnati, OH) Hybrid Surgical Device (K#924160) LCA, Inc. (Cincinnati, OH) Closed End (K#931070) LCA, Inc. (Cincinnati, OH) Closed End/Electrocautery (K#932272) LCA, Inc. (Ci…
Lca, Inc.1993—
*K931070Closed End Fiberoptic Laser Delivery System
Summary page 3
…c. (Cincinnati, OH) R yin - Fiber Cap (K#924120) LCA, Inc. (Cincinnati, OH) Hybrid Surgical Device (K#924160) LCA, Inc. (Cincinnati, OH) Closed End (K#931070) LCA, Inc. (Cincinnati, OH) Closed End/Electrocautery (K#932272) LCA, Inc. (Cincinnati, OH) Bipolar Dissector (K#901365) LCA, I…
Lca, Inc.1993—
*K932272Closed End/Electrocautery Fiberopt Laser Deliv Sys
Summary page 3
…LCA, Inc. (Cincinnati, OH) Hybrid Surgical Device (K#924160) LCA, Inc. (Cincinnati, OH) Closed End (K#931070) LCA, Inc. (Cincinnati, OH) Closed End/Electrocautery (K#932272) LCA, Inc. (Cincinnati, OH) Bipolar Dissector (K#901365) LCA, Inc. (Cincinnati, OH) 1s substantially equivalent to the use of a…
Lc Ent.1993—
*K901365Laser Forceps Handpiece
Summary page 3
…4160) LCA, Inc. (Cincinnati, OH) Closed End (K#931070) LCA, Inc. (Cincinnati, OH) Closed End/Electrocautery (K#932272) LCA, Inc. (Cincinnati, OH) Bipolar Dissector (K#901365) LCA, Inc. (Cincinnati, OH) 1s substantially equivalent to the use of any of the above- mentioned devices when used with any of…
Lca, Inc.1990—
*K914520Diomed 25 Surgical Diode Laser, Urology Applicat
Summary page 3
…above- mentioned devices when used with any of the following medical devices which are used as a laser (energy) source: Diomed" 25, 25W surgical diode laser system (K#s 914520, 914521), Diomedics Inc. (The Woodlands, TX) ZOE Nd:YAG laser system (K#s 909128, 923991), LCA, Inc. (Cincinnati, OH) Section I…
Dio-Med Corp.1993—
*K914521Diomed 25 Surgical Diode Laser, Gen Surg Applicat
Summary page 3
…entioned devices when used with any of the following medical devices which are used as a laser (energy) source: Diomed" 25, 25W surgical diode laser system (K#s 914520, 914521), Diomedics Inc. (The Woodlands, TX) ZOE Nd:YAG laser system (K#s 909128, 923991), LCA, Inc. (Cincinnati, OH) Section III of th…
Dio-Med Corp.1993—
Kept off the family treeK909128ZOE Nd:YAG laser system
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 3
…are used as a laser (energy) source: Diomed" 25, 25W surgical diode laser system (K#s 914520, 914521), Diomedics Inc. (The Woodlands, TX) ZOE Nd:YAG laser system (K#s 909128, 923991), LCA, Inc. (Cincinnati, OH) Section III of this submission provides information in support of this equivalence claim.…
*K923991Zoe Laser, Contact ND:Yag Laser System
Summary page 3
…d as a laser (energy) source: Diomed" 25, 25W surgical diode laser system (K#s 914520, 914521), Diomedics Inc. (The Woodlands, TX) ZOE Nd:YAG laser system (K#s 909128, 923991), LCA, Inc. (Cincinnati, OH) Section III of this submission provides information in support of this equivalence claim. This bel…
Lca, Inc.1993—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 9 ancestors has a recall.

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 Slt-J, Ltd.

3 FDA decisions under this applicant name. See the company

  • K964031DCL8 Enhanced Pulsed ND:Yag Laser SystemSlt-J, Ltd. · 1996
  • K960086DCL8 Enhanced Pulsed ND:Yag Laser SystemSlt-J, Ltd. · 1996

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https://510kreport.com/device/K960905 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960905: SDL Diode Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960905

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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