510(k) Report

510(k) · Cleared

Cleared

Optimedica Laser Indirect Ophthalmoscope

K062336510(k) TraditionalCleared Oct 19, 200670-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

Optimedica Corporation · GEX Powered Laser Surgical Instrument

Cleared on Oct 19, 2006 as substantially equivalent to K924588 (Carl Zeiss, Inc., 1993) and 3 other predicates after a 70-day review. Its family tree reaches back 5 generations to 1989. 1 later device descends from it.

Decided
Oct 19, 2006
Review
70 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K894841 (1989). 39 ancestors in all, the oldest K812219 (1981). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 3 other ancestors1999: 2 other ancestors1993: 3 other ancestors2005: 1 other ancestor2000: 1 other ancestor1996: 1 other ancestor1994: 3 other ancestors1991: 4 other ancestors1989: 5 other ancestors1983: 2 other ancestors1981: 1 other ancestor1998: 1 other ancestor1997: 1 other ancestor1986: 2 other ancestors1984: 2 other ancestors1990: 2 other ancestors2012: 1 descendant clearedK894841 · Iris Oculight (TM) SL · Iriderm Div. · 1989K960971 · Oculight GL · Iriderm Div. · 1996K020374 · Oculight SL/SLX · Iridex Corp · 2002K032357 · Novus TTX Laser and Delivery Devices with Accessories · Lumenis, Inc. · 2003K052526 · Novus 3000 Laser System and Delivery Devices · Lumenis, Inc. · 200519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 11 other ancestors3 generations back: 11 other ancestors4 generations back: 9 other ancestors 1 generation forward: 1 descendant K052526 · Novus 3000 Laser System and Delivery Devices · Lumenis, Inc. · 2005K032357 · Novus TTX Laser and Delivery Devices with Accessories · Lumenis, Inc. · 2003K020374 · Oculight SL/SLX · Iridex Corp · 2002K960971 · Oculight GL · Iriderm Div. · 1996K894841 · Iris Oculight (TM) SL · Iriderm Div. · 1989−50
  1. Root · 5 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
  2. 4 generations backK960971 Oculight GLIriderm Div. · 1996
  3. 3 generations backK020374 Oculight SL/SLXIridex Corp · 2002
  4. 2 generations backK032357 Novus TTX Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2003
  5. 1 generation backK052526 Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005
  6. This deviceK062336 Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006
  7. Descendant · cites it directly · 0 of its ownK123056 Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls) · 2012

Most influential descendants

Showing 1 of 1 · See all
  • K123056Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls) · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K894841Iris Oculight (TM) SLIriderm Div.1989—
−4K960971Oculight GLIriderm Div.1996—
−3K020374Oculight SL/SLXIridex Corp2002—
−2K032357Novus TTX Laser and Delivery Devices with AccessoriesLumenis, Inc.2003—
−1K052526Novus 3000 Laser System and Delivery DevicesLumenis, Inc.2005—
0 (this device)K062336Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation2006—
+1K123056Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls)2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198320
198420
198620
198950
199020
199140
199330
199430
199610
199710
199810
199920
200010
200230
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K062336, 1989–2012Source: 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
*K924588Zeiss Laser Indirect Ophthalmoscope
Summary page 1
…ame or similar technological characteristics (including treatment and aiming wavelengths, spot size, working distance and indirect ophthalmoscope used) as the Zeiss LIO (K924588). The OptiMedica LIO is also substantially equivalent to the delivery devices included in 51 0(k)s K022181 (Novus VARIA and Deliv…
Carl Zeiss, Inc.1993—
*K022181Novus Varia Ophthalmic Laser and Delivery Devices with Accessories
Summary page 1
…g distance and indirect ophthalmoscope used) as the Zeiss LIO (K924588). The OptiMedica LIO is also substantially equivalent to the delivery devices included in 51 0(k)s K022181 (Novus VARIA and Delivery Devices ) and K052526 (Novus 3000 and Delivery Devices ) by Lumenis and K991258 (Novus Verdi Delivery S…
Lumenis, Inc.2002—
*K052526Novus 3000 Laser System and Delivery Devices
Summary page 1
…the Zeiss LIO (K924588). The OptiMedica LIO is also substantially equivalent to the delivery devices included in 51 0(k)s K022181 (Novus VARIA and Delivery Devices ) and K052526 (Novus 3000 and Delivery Devices ) by Lumenis and K991258 (Novus Verdi Delivery Systems) by Coherent. 5.2 DESCRIPTION OF THE…
Lumenis, Inc.2005—
*K991258Novus Verdi Delivery Systems
Summary page 1
…ntially equivalent to the delivery devices included in 51 0(k)s K022181 (Novus VARIA and Delivery Devices ) and K052526 (Novus 3000 and Delivery Devices ) by Lumenis and K991258 (Novus Verdi Delivery Systems) by Coherent. 5.2 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION The OptiMedica…
Lumenis, Inc.1999—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123056Pascal Laser Indirect OphthalmoscopeTopcon Medical Laser Systems, Inc. (Tmls)20120

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 17 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
  • 1 of the 39 ancestors has a recall of any class.
  • Of its descendants, K123056 (Topcon Medical Laser Systems, Inc. (Tmls), 2012) has gone furthest, with 0 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—

What is it indicated for?

The OptiMedica LIO is indicated for the delivery of laser energy in eyes with retinal pathology. The OptiMedica LIO is indicated for use in the following ophthalmic treatments and conditions:

* Diabetic retinopathy (panretinal photocoagulation)

* Macular degeneration

* Peripheral neovascularization

* Retinal breaks

* Retinal detachments

* Retinal tears

* Lattice degeneration

* Pneumatic retinopexy reattachment procedures

* Segmental peripheral photocoagulation

* Segmental photocoagulation

* Cloudy vitreous cavities

* Pediatric retinal repairs (under general anesthesia)

* Delivery of laser energy through small pupils or to eyes with focal lens opacities

Indications for use as stated in the FDA summary.

More from Optimedica Corporation

8 FDA decisions under this applicant name. See the company

  • K161455Catalys Precision Laser SystemOptimedica Corporation · 2016
  • K141079Optimedica Catalys Precision Laser SystemOptimedica Corporation · 20143 recalls
  • K121091Catalys Precision Laser SystemOptimedica Corporation · 20122 recalls
  • K113479Optimedica Catalys Precision Laser SystemOptimedica Corporation · 20112 recalls
  • K100019Pascal Streamline PhotocoagulatorOptimedica Corporation · 20101 recall

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https://510kreport.com/device/K062336 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062336: Optimedica Laser Indirect Ophthalmoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062336

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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