# K020099: Mega Beam/Ceralas Nonsterile Collimating Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec, Inc.
- Decided: Apr 11, 2002 after 90 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. Mega Beam/Ceralas Nonsterile Collimating Handpiece: named in the summary without a submission number

## Indications for use
The biclitec, Inc. Mega Beam/Ceralas Nonsterile Collimating Handpiece is intended to be used as a fiberoptic laser delivery accessory with the CeralasD 980nm Diode Laser for the dental indications that the laser has already been cleared for in K983058, K991891 and K993002. Please refer to the Laser User Manual for the specific list of indications.

Source page: https://510kreport.com/device/K020099
Methodology: https://510kreport.com/methodology