# K061025: Accutech Endolite Probe

- Pathway: 510(k) (Traditional)
- Applicant: Accutech Medical Technologies, Inc.
- Decided: May 31, 2006 after 48 days
- Product code: FFS (Image, Illumination, Fiberoptic, For Endoscope )
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K894841 (1989). 60 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052526: Novus 3000 Laser System and Delivery Devices, Lumenis, Inc. (2005) Summary page 1.
- K931072: HGM Illuminating/Aspirating Endoocular Probe, Hgm, Inc. (1994) Summary page 1.
- K022181: Novus Varia Ophthalmic Laser and Delivery Devices with Accessories, Lumenis, Inc. (2002)
- K964751: Ceralas Diode Laser System (Ceralas D2), Ceram Optec, Inc. (1997)
- K980389: Megabeam Reusable Fiber Optic Handpiece and Needles, Ceram Optec, Inc. (1998) Summary page 1.
- K943445: Megabeam Fiber Optic Delivery System, Ceram Optec, Inc. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K990174: Atlas-Elite,Model E-80,Corium 200,Corium 400, Model E-90, Elite, Model E-80-II, Elite Ultra, Model E-80-IV, Fisma, Inc. (1999). 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.

## Most influential descendants
- K090281: Accutech Family of Powerflex Laser Delivery Devices (2009), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K061025
Methodology: https://510kreport.com/methodology