# K013193: Mega Beam/Ceralas Nonsterile Collimating Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec, Inc.
- Decided: Dec 21, 2001 after 88 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.
No later device cites it as a predicate yet.
0 of 1 device 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 Sterile Fiber optic Delivery System’s Bare Fibers: named in the summary without a submission number
- (no number) Coherent VersaSpot & Collimated Handpiece: named in the summary without a submission number
- (no number) Coherent Ultrafine TrueSpot Collimating Handpiece: named in the summary without a submission number

## Indications for use
The company's MegaBeam/Ceralas NonSterile Collimating Handpiece is intended to be used as a fiber optic delivery accessory to a laser device. Please refer to the Laser User Manual for a complete list of indications.

Source page: https://510kreport.com/device/K013193
Methodology: https://510kreport.com/methodology