# K946336: Megabeam Fiber Optic Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Hogan & Hartson
- Decided: Feb 10, 1995 after 43 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K980389: Megabeam Reusable Fiber Optic Handpiece and Needles (1998), 3 descendants of its own
- K061025: Accutech Endolite Probe (2006), 1 descendant of its own
- K113709: Megabeam Fiber Optic Delivery System with Additional Tips & Handpiece (2012), 0 descendants of its own
- K090281: Accutech Family of Powerflex Laser Delivery Devices (2009), 0 descendants of its own
- K060905: Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1 (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K946336
Methodology: https://510kreport.com/methodology