# K060050: Megabeam Sidefiber Fiber Optic Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec, Inc.
- Decided: Jan 23, 2006 after 17 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.
28 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Biolitec Inc MegaBeam Lateral Fire Fiber Optic Delivery System: named in the summary without a submission number
- (no number) Lumenis DuoTome Side Firing Fiber: named in the summary without a submission number
- (no number) Trimedyne VAPORMAX side firing fiber: named in the summary without a submission number

## 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
- 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

## Indications for use
The Model SF-2100-H MegaBeam SideFiber Fiber Optic Delivery System is intended for use as a fiber optic delivery system in conjunction with any Ho:YAG (holmium) surgical laser with SMA 905 compatible connector. The MegaBeam SideFiber Fiber Optic Delivery System is indicated for hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.

Source page: https://510kreport.com/device/K060050
Methodology: https://510kreport.com/methodology