510(k) Report

510(k) · Cleared

Cleared

Laser Indirect Ophthalmoscope (Lio)

K885196510(k) TraditionalCleared Jan 11, 198926-day reviewClass II21 CFR 886.4150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Coherent Medical Group · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered

Cleared on Jan 11, 1989 after a 26-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 297 later devices descend from it.

Decided
Jan 11, 1989
Review
26 days
Class
Class II
Product code
HQE
Recalls
None
Predicates
0

297 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared1999: 1 descendant cleared2005: 6 descendants cleared2006: 4 descendants cleared2011: 11 descendants cleared2004: 1 descendant cleared2017: 11 descendants cleared2009: 10 descendants cleared2007: 5 descendants cleared2003: 2 descendants cleared2008: 11 descendants cleared2013: 13 descendants cleared2010: 11 descendants cleared2014: 12 descendants cleared2012: 7 descendants cleared2022: 27 descendants cleared2016: 14 descendants cleared2015: 13 descendants cleared2020: 17 descendants cleared2019: 12 descendants cleared2023: 15 descendants cleared2018: 12 descendants cleared2025: 29 descendants cleared2024: 25 descendants cleared2021: 10 descendants cleared2026: 17 descendants cleared1990200020102020
  1. This deviceK885196 Laser Indirect Ophthalmoscope (Lio)Coherent Medical Group · 1989
  2. Descendant · cites it directly · 296 of its ownK991258 Novus Verdi Delivery SystemsLumenis, Inc. · 1999
  3. Descendant · 2 generations on · 225 of its ownK050738 FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · Recalled
  4. Descendant · 3 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
  5. Descendant · 4 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
  6. Descendant · 5 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008

Showing 5 of 297 descendants. See all descendants

Descendants cleared per year

1999: 12002: 12003: 22004: 12005: 62006: 42007: 52008: 112009: 102010: 112011: 112012: 72013: 132014: 122015: 132016: 142017: 112018: 122019: 122020: 172021: 102022: 272023: 152024: 252025: 292026: 17
1999high 29 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 297 · See all
  • K991258Novus Verdi Delivery SystemsLumenis, Inc. · 1999 · cites it directly296descendants
  • K050738FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · 2 generations on225descendants
  • K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 3 generations on221descendants
  • K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 4 generations on202descendants
  • K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 5 generations on192descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K885196Laser Indirect Ophthalmoscope (Lio)Coherent Medical Group1989—
+1K991258Novus Verdi Delivery SystemsLumenis, Inc.1999—
+2K050738FT Fiber Optic Delivery SystemsFibertech GmbH20055
+3K060033Profile Multi-Platform SystemSciton, Inc2006—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200210
200320
200410
200560
200640
200750
2008110
2009100
2010110
2011110
201270
2013130
2014120
2015130
2016140
2017110
2018120
2019120
2020170
2021100
2022270
2023150
2024250
2025290
2026170
FIG. 1 — Lineage of K885196, 1989–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HQE? 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 HQE device

  1. #1 K212763 UniVit HE, UniVit UHSscore 4.1 · 2 generations · no Class I recall
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (297)

See all 297

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

NumberDeviceApplicantDecidedDescendants
K991258Novus Verdi Delivery SystemsLumenis, Inc.1999296
K022181Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesLumenis, Inc.200265

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, K991258 (Lumenis, Inc., 1999) has gone furthest, with 296 descendants of its own.

How does its category compare?

All HQE devices

HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQE

1in 2022

2011: 12012: 22014: 12016: 12017: 12022: 1
2007high 2 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQE

Too few HQE 510(k)s in any year since 2007 to give a median.

Recalls per year · HQE

1in 2025

2007: 22010: 112016: 42025: 12026 (partial year): 3
2007high 11 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HQE

339in 2025

2007: 3002008: 652009: 342010: 272011: 212012: 342013: 92014: 92015: 92016: 102017: 592018: 3092019: 412020: 302021: 322022: 462023: 1082024: 1052025: 339
2007high 339 (2025) · low 9 (2013)2025

MAUDE reports naming product code HQE, 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
20070—2300
20080—065
20090—034
20100—1127
20111—021
20122—034
20130—09
20141—09
20150—09
20161—410
20171—059
20180—0309
20190—041
20200—030
20210—032
20221—046
20230—0108
20240—0105
20250—1339
20260—3—

More from Coherent Medical Group

27 FDA decisions under this applicant name. See the company

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  • K923575Coherent Versapluse 2.1 Holmium Surg. LasersCoherent Medical Group · 1993
  • K932468Novus MultiwavelengthCoherent Medical Group · 1993

Recent decisions in HQE

The HQE category page

  • K212763UniVit HE, UniVit UHSVisioncare Devices, LLC · 2022
  • K170183Cetus system, Cetus probeA.R.C Laser GmbH · 2017
  • K153168Bi-Blade Vitrectomy CutterMedical Instrument Development Laboratories · 2016
  • K141065Constellation Vision SystemAlcon Research, Ltd. · 20146 recalls
  • K121675VersavitSynergetics, Inc. · 20124 recalls

https://510kreport.com/device/K885196 · printed Nov 6, 2026

Cite this page

510(k) Report. “K885196: Laser Indirect Ophthalmoscope (Lio).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K885196

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