# K943527: Megabeam Lateral Fire

- Pathway: 510(k) (Traditional)
- Applicant: Ceram Optec, Inc.
- Decided: Dec 5, 1994 after 137 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.
29 later devices descend from it; 3 cite it directly.
0 of 30 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
- K112987: Twister Side Fire Optical Fiber Delivery System (2011), 27 descendants of its own
- K121127: Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength Lasers (2012), 25 descendants of its own
- K120810: Fiberoptic Laser Delivery System (2012), 24 descendants of its own
- 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

Source page: https://510kreport.com/device/K943527
Methodology: https://510kreport.com/methodology