# K113792: Megabeam Endocular Probe and Aspirating Endocular Probe

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec Medical Devices, Inc.
- Decided: Jan 19, 2012 after 27 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K935747 (1994). 2 ancestors in all.
24 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935747: Megabeam Endocular Probe, Ceram Optec, Inc. (1994) Summary page 1.
- K952340: Megabeam Aspirating Endocular Probe, Ceram Optec, Inc. (1995) Summary page 1.

## Most influential descendants
- K124003: Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and Aspirating Laser Probes, Med-Fibe (2013), 23 descendants of its own
- K170366: Laser Peripherals, LLC Family of Bare Laser Fibers (2017), 13 descendants of its own
- K220189: LISA Laser Surgical Fibers (2022), 5 descendants of its own
- K140470: Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission Fiber, Dental Surgery Fiber (2014), 5 descendants of its own
- K131473: (Quanta System) Surgical Laser Fibers (2013), 5 descendants of its own

## Indications for use
The MegaBeam Endocular Probe and Aspirating Endocular Probe are intended for intraocular photocoagulation with or without simultaneous aspiration/irrigation as an adjunct to vitrectomy surgery. Specific indications include the treatment of proliferative vitreoretinopathy, tractional retinal detachments, proliferative diabetic retinopathy, and various retinal vascular tumors.

Source page: https://510kreport.com/device/K113792
Methodology: https://510kreport.com/methodology