510(k) · Cleared
ClearedAccutech Endolite Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accutech Medical Technologies, Inc. · FFS Image, Illumination, Fiberoptic, For Endoscope
Cleared on May 31, 2006 as substantially equivalent to K052526 (Lumenis, Inc., 2005) and 5 other predicates after a 48-day review. Its family tree reaches back 5 generations to 1989. 1 later device descends from it.
- Decided
- May 31, 2006
- Review
- 48 days
- Class
- Class II
- Product code
- FFS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 5 generations to K894841 (1989). 60 ancestors in all, the oldest K812219 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 4 generations backK960971 Oculight GLIriderm Div. · 1996
- 3 generations backK020374 Oculight SL/SLXIridex Corp · 2002
- 2 generations backK032357 Novus TTX Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2003
- 1 generation backK052526 Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005
- This deviceK061025 Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK090281 Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −4 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −3 | K020374 | Oculight SL/SLX | Iridex Corp | 2002 | — |
| −2 | K032357 | Novus TTX Laser and Delivery Devices with Accessories | Lumenis, Inc. | 2003 | — |
| −1 | K052526 | Novus 3000 Laser System and Delivery Devices | Lumenis, Inc. | 2005 | — |
| 0 (this device) | K061025 | Accutech Endolite Probe | Accutech Medical Technologies, Inc. | 2006 | — |
| +1 | K090281 | Accutech Family of Powerflex Laser Delivery Devices | Accutech Medical Technologies, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 2 | 0 |
| 1984 | 2 | 0 |
| 1986 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 11 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
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 FFS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (7)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052526 | Novus 3000 Laser System and Delivery DevicesSummary page 1…Primary Classification Names: Accessory for, Laser Powered Surgical Instruments III. Predicate Devices * Lumenis Endo~cular Probes (K052526, K(931072, K990174, K(02218 1) * CeramOptec/BioLitec EndoProbe (K(96475 1) * CeramOptec MegaBeam Fiber Opti… | 2005 |
| * | K931072 | HGM Illuminating/Aspirating Endoocular ProbeSummary page 1…Primary Classification Names: Accessory for, Laser Powered Surgical Instruments III. Predicate Devices * Lumenis Endo~cular Probes (K052526, K(931072, K990174, K(02218 1) * CeramOptec/BioLitec EndoProbe (K(96475 1) * CeramOptec MegaBeam Fiber Optic Delivery… | 1994 |
| Kept off the family tree | K990174 | FDA’s K990174 is Atlas-Elite,Model E-80,Corium 200,Corium 400, Model E-90, Elite, Model… Our reading of the summary gave K990174, FDA’s number for Atlas-Elite,Model E-80,Corium 200,Corium 400, Model E-90… (Fisma, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Lumenis Endo~cular Probes”. Kept off the family tree. Summary page 1…Classification Names: Accessory for, Laser Powered Surgical Instruments III. Predicate Devices * Lumenis Endo~cular Probes (K052526, K(931072, K990174, K(02218 1) * CeramOptec/BioLitec EndoProbe (K(96475 1) * CeramOptec MegaBeam Fiber Optic Delivery System (… | 1999 |
| * | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with Accessories | 2002 |
| * | K964751 | Ceralas Diode Laser System (Ceralas D2) | 1997 |
| * | K980389 | Megabeam Reusable Fiber Optic Handpiece and NeedlesSummary page 1…cular Probes (K052526, K(931072, K990174, K(02218 1) * CeramOptec/BioLitec EndoProbe (K(96475 1) * CeramOptec MegaBeam Fiber Optic Delivery System (K980389.,K943445) IV. Product Description The Accutech EndoLite Probe is comprised of the following main components:… | 1998 |
| * | K943445 | Megabeam Fiber Optic Delivery SystemSummary page 1…bes (K052526, K(931072, K990174, K(02218 1) * CeramOptec/BioLitec EndoProbe (K(96475 1) * CeramOptec MegaBeam Fiber Optic Delivery System (K980389.,K943445) IV. Product Description The Accutech EndoLite Probe is comprised of the following main components:… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090281 | Accutech Family of Powerflex Laser Delivery Devices | 2009 | 0 |
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 60 ancestors has a recall of any class.
- Of its descendants, K090281 (Accutech Medical Technologies, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K052526.
How does its category compare?
All FFS devicesFFS Image, Illumination, Fiberoptic, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FFS
3in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · FFS
74in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FFS
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFS
5in 2024
MAUDE reports naming product code FFS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 74 | 1 | 12 |
| 2008 | 0 | — | 0 | 17 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 17 |
| 2020 | 0 | — | 0 | 56 |
| 2021 | 0 | — | 0 | 57 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Accutech EndoLite Probe is intended for use in the treatment of ocular pathology.
The Accutech EndoLite Probe is indicated for use in ocular photocoagulation of the anterior and posterior segment for the indications for use cleared for the 532-659 nm laser system(s) with which it is compatible for use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061025 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061025: Accutech Endolite Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061025
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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